INCIVEK (750 mg) is given as two 375-mg tablets three times daily for 12 weeks. It is packaged in weekly boxes that include daily blister strips to help patients keep track of their doses.
Important Links;
Telaprevir/Incivek Prescribing Information
Medication Guide
Financial Assistance and Patient Support Program for INCIVEK
FDA Press Release;
, ,.
FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C
-79% of people treated for the first time achieved a SVR (viral cure) with INCIVEK combination treatment-
-Vertex launches a comprehensive financial assistance and patient support program-
-Conference call today at 11:00 a.m. ET to provide more information on the commercialization of INCIVEK-
.
The approval of INCIVEK was based on data from three Phase 3 studies, which showed that people who received INCIVEK combination treatment achieved significantly higher rates of sustained viral response (SVR, or viral cure) compared to those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience:
People new to treatment: | 79 percent vs. 46 percent | ||
People who were treated previously but did not achieve a viral cure: | |||
-- Relapsers: | 86 percent vs. 22 percent | ||
-- Partial responders: | 59 percent vs. 15 percent | ||
-- Null responders: | 32 percent vs. 5 percent | ||
INCIVEK (750 mg) is given as two 375-mg tablets three times daily. It is packaged in weekly boxes that include daily blister strips to help patients keep track of their doses.
Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.
"Hepatitis C can lead to liver failure, cancer and the need for a transplant, and for the past decade, the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half of them," said
"Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure," said
.
Vertex has 200 field-based employees across
.
Helping People with Hepatitis C Get INCIVEK
The people who work at Vertex understand that medicines can only help patients who can get them. With that in mind, the company today introduced a comprehensive financial assistance and patient support program to help people get INCIVEK who might not otherwise be able to afford it. The program will help people with hepatitis C learn about insurance benefits for their medicines, give INCIVEK for free to eligible patients who do not have insurance and provide coverage for co-pay or co-insurance costs associated with INCIVEK for people who meet certain program criteria.
Additionally, patients will have access to nurses through a 24-7 hotline by which they can receive support, guidance and educational materials about hepatitis C and its treatment. Vertex will also provide nurses and doctors with educational tools and resources so they can offer support and care to people with hepatitis C before, during and after the treatment process.
For eligible patients, the program includes the following:
Insurance Benefits Research and Support: Vertex case managers will research patients' insurance benefits for INCIVEK combination treatment, assist people with insurance appeals and help guide them to other forms of financial support, including Vertex's free medicine and co-pay programs;- Free Medicine Program: Vertex will give INCIVEK for free to people who do not have insurance and have an annual household income of
$100,000 or less; and - Co-Pay Support: Vertex will cover co-pay or co-insurance costs up to 20 percent of the total cost of INCIVEK for people who have private insurance plans that cover INCIVEK, regardless of their household income. For people covered by government insurance, Vertex will also make donations to the independent, non-profit
Patient Access Network Foundation , which has a fund to provide co-pay support to people taking hepatitis C medicines.
.
About INCIVEK
INCIVEK is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. The Phase 3 registration studies evaluated INCIVEK in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people with hepatitis C who were new to treatment as well as those who were treated previously with pegylated-interferon and ribavirin but who did not achieve a viral cure, including:
- Prior Relapsers: Defined as people whose hepatitis C virus was undetectable after a full course of previous treatment, but whose virus became detectable during the follow-up period;
- Prior Partial Responders: Defined as people who achieved at least a 2 log10 reduction in hepatitis C virus at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy; and
- Prior Null Responders: Defined as people who achieved a less than 2 log10 reduction in hepatitis C virus at week 12 of a prior course of therapy.
.
Indication
INCIVEK™ (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.
It is not known if INCIVEK is safe and effective in children under 18 years of age.
.
IMPORTANT SAFETY INFORMATION
Who should not take INCIVEK?
Do not take INCIVEK if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
Do not take INCIVEK if you are taking certain medicines as there could be serious side effects. If these drugs are taken together, this can cause you to have too much or not enough INCIVEK or your other medicines in your body. It can also cause side effects that can be serious or life-threatening. These medicines include: alfuzosin hydrochloride (Uroxatral®), atorvastatin (Lipitor®, Caduet®), ergot containing medicines such as methylergonovine (Methergine®), lovastatin (Advicor®, Altoprev®, Mevacor®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®), sildenafil citrate (Revatio®) or tadalafil (Adcirca®) for the lung problem pulmonary artery hypertension (PAH), simvastatin (Zocor®, Vytorin®,
Talk to your healthcare provider before taking INCIVEK if any of the above applies to you. Your healthcare provider may need to change the amount of medicines you take.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. INCIVEK and other medicines can affect each other.
.
Serious Side Effects
INCIVEK can cause serious side effects, including:
- Birth defects or death of an unborn baby
INCIVEK combined with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you or your sexual partner is pregnant or plan to become pregnant, do not take these medicines. You or your partner should not become pregnant while taking INCIVEK with peginterferon alfa and ribavirin and for 6 months after treatment is over.
You must have a negative pregnancy test before starting treatment, every month during treatment, and for 6 months after your treatment ends. You must use 2 effective methods of birth control during treatment and for 6 months after all treatment has ended. These 2 forms of birth control should not contain hormones, as these may not work as well during treatment with INCIVEK. Talk to your healthcare provider about the forms of birth control you should use during this time.
Two weeks after stopping INCIVEK, you can use a hormonal form of birth control as one of your two forms of birth control.
If you or your partner becomes pregnant during treatment or within 6 months after stopping these medicines, tell your healthcare provider right away. Contact the Ribavirin Pregnancy Registry right away by calling 1-800-593-2214. The Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while pregnant.
- Skin reactions: Mild skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become severe and require treatment in a hospital.
Call your healthcare provider right away if you develop any skin changes with these symptoms: rash with or without itching, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes like "pink eye" (conjunctivitis), swelling of your face, or fever.
Your healthcare provider will decide if these changes may be a sign of a serious skin reaction. Your healthcare provider will also decide if you need treatment for your rash or to stop INCIVEK or your other medicines. Never stop taking INCIVEK combination treatment without talking to your healthcare provider first.
- Do not take INCIVEK alone to treat chronic hepatitis C infection. It must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.
- Low red blood cell count (anemia) that can be severe. Tell your healthcare provider if you have any of these symptoms of anemia: dizziness, shortness of breath, tiredness, or weakness.
Your healthcare provider will do blood tests regularly to check your red blood cell count during treatment. If your anemia is severe your healthcare provider may tell you to stop taking INCIVEK. If this happens, do not start taking it again.
Tell your healthcare provider if you:
- have certain blood problems such as anemia
- have liver problems other than hepatitis C infection
- have hepatitis B, HIV infection, or any problems with your immune system
- have a history of gout or high uric acid levels in your blood
- have had an organ transplant
- plan to have surgery
- have any other medical condition
- are breastfeeding
Take INCIVEK exactly as your healthcare provider tells you. Take 2 INCIVEK pills 3 times a day, 7 to 9 hours apart, with food. Eat a meal or snack containing about 20 grams of fat within 30 minutes before you take each dose. Talk to your healthcare provider about examples of food you can eat.
If you miss a dose within 4 hours of when you usually take it, take your dose with food as soon as possible. If you miss a dose and it is more than 4 hours after the time you usually take it, skip that dose only and take the next dose at your normal time. Do not stop taking INCIVEK unless your healthcare provider tells you to. If your healthcare provider tells you to stop, you should not start taking it again, even if the reason for stopping goes away. If you take too much INCIVEK, call your healthcare provider or local
.
Common Side Effects of INCIVEK Combination Treatment
The most common side effects include itching, nausea, diarrhea, vomiting, anal or rectal problems (including hemorrhoids, discomfort or burning around or near the anus, itching around or near the anus), taste changes, and tiredness. Tell your healthcare provider about any side effect that bothers you or doesn't go away.
These are not all the possible side effects of INCIVEK. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the
You may also report side effects to
Please see full Prescribing Information for INCIVEK including the Medication Guide available at www.INCIVEK.com.
For healthcare providers who are interested in information about INCIVEK, you can also call 1-877-824-4281.
.
Conference Call Information
Vertex will host a conference call and webcast today, May, 23, 2011 at
INCIVEK™ is a trademark of
PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche.
.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C is curable.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6 In
.
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in
.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding (i) Vertex's sales team being ready to support the introduction of INCIVEK, (ii) Vertex's financial assistance and patient support programs and its commitment to help people who might not otherwise be able to afford INCIVEK receive it and (iii) the use of INCIVEK as a treatment for people with genotype 1 chronic hepatitis C virus infection. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, risks related to the commercialization of INCIVEK and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the
.
For more information and to view Vertex's press releases, please visit www.vrtx.com.
(VRTX - GEN)
1
2 Pearlman BL and
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
9
Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx.
Updated
10 Pyenson B, Fitch K,
Available at: http://www.natap.org/2009/HCV/051809_01.htm.
Updated
11
12 Davis GL, Alter MJ,
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6733469&lang=en
.
.
FDA OKs Telaprevir for Hep CBy Emily P. Walker, Washington Correspondent,
MedPage Today
Published: May 23, 2011
The FDA has approved telaprevir (Incivek) for treatment of hepatitis C genotype 1, making it the second new protease inhibitor to win agency approval for the condition this month.
Hepatitis C affects some three to four million people in the U.S.; about two-thirds have genotype 1.The approval was all but certain after an FDA advisory committee unanimously endorsed telaprevir, made by Vertex Pharmaceuticals, in April. On May 13, the agency announced it is approving Merck's boceprevir (Victrelis).
Telaprevir and boceprevir work by targeting the virus directly; the current standard treatment regimen of pegylated interferon and ribavirin works instead by boosting patients' immune responses.
Both telaprevir and boceprevir are indicated as add-on treatment to pegylated interferon and ribavirin.
Telaprevir comes in pill form and is taken three times a day for 12 weeks, with peginterferon and ribavirin at standard doses for 24 or 48 weeks, depending on virologic response.
Adding a protease inhibitor to peginterferon and ribavirin is expected to become the new standard of care for HCV genotype 1 patients.
About half of patients treated with the standard peginterferon and ribavirin combo achieve sustained viral responses. The telaprevir trials indicated that adding the protease inhibitor could boost the sustained response rate above 70%, to as much as 90%, in patients who had never been treated for HCV, according to results from one study.
"With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," said Edward Cox, MD, MPH, director of the FDA's Office of Antimicrobial Products.
"The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection," Cox said.
The FDA advisory panel that reviewed telaprevir was extremely confident that the drug works but was concerned about an increased incidence of serious and life-threatening skin reactions, including three cases of Stevens-Johnson syndrome in patients who took telaprevir.
More than half of patients receiving the drug reported rash or pruritus, with 6% discontinuing treatment as a result. These rates were about double those in the control groups.
Vertex assured the panel that those side effects are generally manageable and resolve after the drug is stopped.
Vertex hepatitis C drug OK'd, promising more cures
NEW YORK |
NEW YORK (Reuters) - Vertex Pharmaceuticals Inc's highly anticipated hepatitis C drug won U.S. approval, promising far higher cure rates for the liver-destroying disease and setting up a head-to-head marketing battle with a rival new medicine from Merck & Co.,
Incivek, a pill also known as telaprevir, is poised to help transform treatment of hepatitis C by nearly doubling the chances of curing the serious liver disease compared with current standard treatments. Some industry analysts project Incivek sales will top $5 billion a year.
..
Vertex set a wholesale price of $49,200 for a 12-week regimen of Incivek, which works in combination with current standard drugs pegylated interferon and ribavirin. The older treatments are then continued for as few as another 12 weeks.
.
Merck's recently approved Victrelis has a wholesale price of $1,100 per week, or between $26,400 and $48,400 for a course of treatment, depending on needed duration.
Vertex said it was initiating a co-pay assistance program that would reimburse the out-of-pocket costs for the majority of patients covered by commercial health insurance, which accounts for about 60 percent of its expected patient mix.
The approval, which the Food and Drug Administration announced on Monday, was widely expected after an advisory panel unanimously recommended the drug last month.
Vertex said it anticipated approval late this year for Europe, where Johnson & Johnson holds the marketing rights.
Vertex said Incivek, its first commercial product, would arrive in pharmacies this week. The company expects to become profitable next year.
Chief Executive Officer Matthew Emmens said the Incivek approval was the culmination of a $4 billion investment for developing the drug from the beginning in its own labs.
Joshua Boger, Vertex founder and former CEO who pinned the company's fortunes on telaprevir long before the drug had proved itself in clinical trials, said it was "a great day for patients that we at Vertex envisioned almost 18 years ago."
In clinical studies, as many as 79 percent of patients taking Incivek experienced a sustained virologic response -- which is tantamount to a cure. Older drugs cure only about 40 percent of patients.
INCIVEK VS VICTRELIS
Doctors say thousands of hepatitis C patients have been delaying treatment in anticipation of the new medicines because the older drugs had to be taken for 48 weeks, often caused flu-like symptoms and offered a disappointing cure rate.
Incivek offers the potential of cutting the treatment duration to 24 weeks for many patients, while Victrelis can cut treatment down to 28 weeks for some.
About 170 million people around the world are infected with hepatitis C, some 3.2 million of them in the United States. The blood-borne disease can lead to liver cancer, cirrhosis, liver transplants and death.
On May 13, the FDA approved Victrelis, which works the same way as Incivek and is also taken with the older medicines.
Analysts expect Incivek to eventually control more of the market because it has shown a higher cure rate. Victrelis had a 66 percent cure rate in late-stage studies, although the new drugs have not been tested against each other.
"There are now two important new treatment options for hepatitis C that offer a greater chance at a cure," said Edward Cox, director of the FDA drug center's office of antimicrobial products.
The most commonly reported side effects with Incivek include rashes and anemia, the FDA said. The rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.
The Incivek label says only 4 percent of patients reported a severe rash, Sanford Bernstein analyst Geoffrey Porges said.
"We do not see this as a significant limitation to adoption," Porges said.
Some analysts have projected market share splits of 70-30 or higher in favor of Vertex, including Jason Kantor of RBC Capital Markets.
"At the end of the day Vertex has the better drug profile, simpler drug to use and I still expect Vertex to get the lion's share of the market," Kantor said.
Last week Merck struck a deal with Roche Holding AG, which will co-promote Victrelis in the United States. Roche and Merck dominate the market for interferons.
"There's certainly some pricing strategies around interferons that Merck and Roche may be able to use," Brean Murray, Carret & Co analyst Brian Skorney said.
Vertex shares closed up 81 cents, or 1.5 percent at $55.81 on Nasdaq, while Merck shares fell 16 cents to $36.90 on the New York Stock Exchange.
(Additional reporting by Toni Clarke in Boston; editing by John Wallace, Maureen Bavdek and Lisa Von Ahn)
Related; Study: Threat of Hepatitis Underestimated
Vertex::
Media:
617-444-6992 or mediainfo@vrtx.com
or
Investors:
Source:
News Provided by Acquire Media
.
.
No comments:
Post a Comment