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U.S. Prescribing InformationPatient Information
U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C
October 10 2014
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source - FDA
U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C
FOSTER CITY, Calif. --(BUSINESS WIRE)--Oct. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA ) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the tradename Sovaldi® in December 2013 . Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.
The FDA granted Harvoni a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over available therapies.
“By providing very high cure rates in as little as eight weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States,” saidNezam Afdhal , MD, Director of Hepatology at Beth Israel Deaconess Medical Center , Professor of Medicine at Harvard Medical School and a principal investigator in the Harvoni clinical trials. “For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12 weeks.”
Harvoni’s approval is supported by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).
Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent.
“Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as little as eight weeks,” saidJohn C. Martin , PhD, Chairman and Chief Executive Officer, Gilead Sciences . “Gilead is proud to have played a role in developing a once-daily therapy that is safe, simple and well tolerated. We are now working to ensure rapid and broad access to Harvoni.”
Important Safety Information regarding warnings and precautions, adverse reactions and drug interactions is listed below. Zero percent, less than 1 percent and 1 percent of patients treated for eight, 12 and 24 weeks, respectively, discontinued treatment due to adverse events and fewer adverse events were observed in the ribavirin-free arms compared to the ribavirin-containing arms in all ION studies. The most common adverse reactions among patients treated with Harvoni (≥5 percent) were fatigue, headache, nausea, diarrhea and insomnia. For additional study details, and complete dosing information, see the Clinical Studies and Dosage and Administration sections, respectively, of the full Prescribing Information.
U.S. Patient Support Program
To assist eligible hepatitis C patients inthe United States with access to Harvoni, Gilead has added the medicine to its Support Path™ (www.MySupportPath.com) program. The program consists of an integrated offering of support services for patients and providers, among them:
To learn more about Support Path for Harvoni or Sovaldi, please visit www.MySupportPath.com or call 1-855-769-7284 between9:00 a.m. – 8:00 p.m. Eastern, Monday through Friday.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.
Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi).
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue and headache.
Drug Interactions
In addition to rifampin and St. John’s wort, coadministration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
Coadministration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.
Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.
AboutGilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California , Gilead has operations in North and South America , Europe and Asia Pacific .
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not see advantages of Harvoni over other therapies and may therefore be reluctant to prescribe the product, and the risk that private and public payers may be reluctant to provide coverage or reimbursement for the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter endedJune 30, 2014 , as filed with the U.S. Securities and Exchange Commission . All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
U.S. FDA approves Gilead's $94,500 hepatitis C drug
By Deena Beasley
Fri Oct 10, 2014 4:36pm EDT
(Reuters) - U.S. regulators on Friday approved a new hepatitis C pill from Gilead Sciences Inc, which said it will charge $94,500 for an improved 12-week course of treatment to rid patients of the liver-destroying viral infection.
The daily pill, to be sold under the brand name Harvoni, combines Gilead's $84,000 pill Sovaldi with another drug, ledipasvir, and eliminates the need for two older, side-effect-laden treatments that needed to be taken along with Sovaldi.
Gilead, which has faced a backlash from health insurers over the high cost of its hepatitis C treatments, said the current regimen of Sovaldi plus the older drugs, interferon and ribavirin, has a cost of $94,726.
The company emphasized that the price of the new drug is less than the current regimen, but insurers and other payers said it is still unsustainable.
"Unfortunately, we believe that the price being demanded is still inappropriately high for a product targeting such a large group of patients," said David Whitrap, spokesman for Express Scripts Holding Co, the largest manager of pharmacy benefit programs in the United States. "New innovations do not always require inappropriate, premium pricing."
Hepatitis C, estimated to infect about 3.2 million Americans, is a viral disease that causes inflammation of the liver that can lead to liver failure.
Gilead said nearly half of patients infected with the most common type of hepatitis C - previously untreated, healthier individuals - can be cured after eight weeks of taking Harvoni, compared with 12 weeks for the current Sovaldi regimen.
The cost of treating those patients with the new pill for eight weeks is $63,000.
Wall Street analysts note that the price of Harvoni is lower than the $130,000 or more now needed to treat certain hepatitis C patients with Sovaldi and Olysio, a newer antiviral drug sold by Johnson & Johnson.
"The price of $94,000 is very attractive," said RBC Capital Markets analyst Michael Yee. "At eight weeks of therapy, the cost is about $63,000, which is 30 percent cheaper than Sovaldi."
Deutsche Bank analyst Robyn Karnauskas said Harvoni's pricing came in slightly below her expectations, but is "rational and strongly supportive of sustained market share."
Bristol-Myers Squibb Co said on Tuesday it is no longer seeking U.S. approval for an oral two-drug combination to treat hepatitis C because of competition from rival drugs.
AbbVie Inc is slated to hear from the FDA later this year on its application to market an all-oral hepatitis C regimen.
"As the additional hepatitis C drugs are approved over the next few months, we're looking forward to driving more competition in this space," Express Scripts said.
October 10 2014
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”
Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.
Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.
Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.
In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.
The most common side effects reported in clinical trial participants were fatigue and headache.
Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases.
Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases.
Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source - FDA
U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C
-- Harvoni Achieved Cure Rates (SVR12) of 94-99 Percent in Three Phase 3 Studies
-- Shortens Treatment Duration to Just Eight Weeks for Certain Treatment-Naïve Patients
-- Eliminates Need for Interferon and Ribavirin for Patients with Genotype 1 Hepatitis C
“By providing very high cure rates in as little as eight weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States,” said
Harvoni’s approval is supported by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).
Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent.
“Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as little as eight weeks,” said
Important Safety Information regarding warnings and precautions, adverse reactions and drug interactions is listed below. Zero percent, less than 1 percent and 1 percent of patients treated for eight, 12 and 24 weeks, respectively, discontinued treatment due to adverse events and fewer adverse events were observed in the ribavirin-free arms compared to the ribavirin-containing arms in all ION studies. The most common adverse reactions among patients treated with Harvoni (≥5 percent) were fatigue, headache, nausea, diarrhea and insomnia. For additional study details, and complete dosing information, see the Clinical Studies and Dosage and Administration sections, respectively, of the full Prescribing Information.
U.S. Patient Support Program
To assist eligible hepatitis C patients in
- Call center staffed with associates trained to help patients and their providers with insurance-related needs.
- Education and support, including a 24/7 nursing support service line.
- The Harvoni and Sovaldi Co-pay Coupon Programs, which provide co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs. Most patients will pay no more than
$5 per co-pay. - The Support Path Patient Assistance Program, which will provide Harvoni and Sovaldi at no charge for eligible patients with no other insurance options.
To learn more about Support Path for Harvoni or Sovaldi, please visit www.MySupportPath.com or call 1-855-769-7284 between
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.
Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi).
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue and headache.
Drug Interactions
In addition to rifampin and St. John’s wort, coadministration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
Coadministration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.
Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.
About
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not see advantages of Harvoni over other therapies and may therefore be reluctant to prescribe the product, and the risk that private and public payers may be reluctant to provide coverage or reimbursement for the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended
U.S. Full Prescribing Information for Harvoni and Sovaldi is available at www.gilead.com.
Harvoni, Sovaldi and Support Path are trademarks or registered trademarks of Gilead Sciences, Inc. , or its related companies.
U.S. FDA approves Gilead's $94,500 hepatitis C drug
By Deena Beasley
Fri Oct 10, 2014 4:36pm EDT
(Reuters) - U.S. regulators on Friday approved a new hepatitis C pill from Gilead Sciences Inc, which said it will charge $94,500 for an improved 12-week course of treatment to rid patients of the liver-destroying viral infection.
The daily pill, to be sold under the brand name Harvoni, combines Gilead's $84,000 pill Sovaldi with another drug, ledipasvir, and eliminates the need for two older, side-effect-laden treatments that needed to be taken along with Sovaldi.
Gilead, which has faced a backlash from health insurers over the high cost of its hepatitis C treatments, said the current regimen of Sovaldi plus the older drugs, interferon and ribavirin, has a cost of $94,726.
The company emphasized that the price of the new drug is less than the current regimen, but insurers and other payers said it is still unsustainable.
"Unfortunately, we believe that the price being demanded is still inappropriately high for a product targeting such a large group of patients," said David Whitrap, spokesman for Express Scripts Holding Co, the largest manager of pharmacy benefit programs in the United States. "New innovations do not always require inappropriate, premium pricing."
Hepatitis C, estimated to infect about 3.2 million Americans, is a viral disease that causes inflammation of the liver that can lead to liver failure.
Gilead said nearly half of patients infected with the most common type of hepatitis C - previously untreated, healthier individuals - can be cured after eight weeks of taking Harvoni, compared with 12 weeks for the current Sovaldi regimen.
The cost of treating those patients with the new pill for eight weeks is $63,000.
Wall Street analysts note that the price of Harvoni is lower than the $130,000 or more now needed to treat certain hepatitis C patients with Sovaldi and Olysio, a newer antiviral drug sold by Johnson & Johnson.
"The price of $94,000 is very attractive," said RBC Capital Markets analyst Michael Yee. "At eight weeks of therapy, the cost is about $63,000, which is 30 percent cheaper than Sovaldi."
Deutsche Bank analyst Robyn Karnauskas said Harvoni's pricing came in slightly below her expectations, but is "rational and strongly supportive of sustained market share."
Bristol-Myers Squibb Co said on Tuesday it is no longer seeking U.S. approval for an oral two-drug combination to treat hepatitis C because of competition from rival drugs.
AbbVie Inc is slated to hear from the FDA later this year on its application to market an all-oral hepatitis C regimen.
"As the additional hepatitis C drugs are approved over the next few months, we're looking forward to driving more competition in this space," Express Scripts said.
Gilead is expected to reap nearly $12 billion in hepatitis C drug sales worldwide in 2014. Sovaldi sales have been unprecedented for any first-year drug.
Gilead shares closed 2 percent lower at $103.73 on Friday.
(Additional reporting by Bill Berkrot in New York; editing by Tom Brown and Matthew Lewis)
(Additional reporting by Bill Berkrot in New York; editing by Tom Brown and Matthew Lewis)
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