FDA News & Notes;
Wednesday, 4/27 – Antiviral Drugs Advisory Committee Meeting discusses a new drug for boceprevir, a hepatitis C virus protease inhibitor, made by Merck & Co. Inc. Proposed for treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults whose liver is damaged but still has the ability to function and who have not been previously untreated or who have failed previous therapy. 8 a.m., 10903 New Hampshire Ave., Room 1503, White Oak Conference Center, Bldg. 31, Silver Spring, Md. The meeting will be webcast.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Thursday, 4/28 – Antiviral Drugs Advisory Committee Meeting will discuss a new drug application for telaprevir, a hepatitis C virus protease inhibitor, manufactured by Vertex Pharmaceuticals Inc. Proposed for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults whose liver is damaged but still has the ability to function and who have not been previously treated or who have failed previous therapy. 8 a.m., 10903 New Hampshire Ave., Room 1503, White Oak Conference Center, Bldg. 31, Silver Spring, Md. The meeting will be webcast.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
From xconomy.com;
Wednesday-Boceprevir Thursday-Telaprevir: Goes Before The FDA Advisory Panel This Week.
US FDA sees safety issue with Merck hepatitis drug
WASHINGTON |
WASHINGTON (Reuters) - U.S. drug reviewers have raised questions about safety issues with an experimental Merck & Co hepatitis drug, including anemia and reports of psychiatric problems, documents released on Monday said.A main issue for discussion is the increase in anemia in patients treated with boceprevir, Food and Drug Administration staff said in a summary prepared for an advisory panel that will review the drug on Wednesday.
Another "potential safety signal" is a higher number of patients who reported psychiatric symptoms such as suicidal and homicidal thoughts, the FDA reviewers said. But they added it was "difficult to make any meaningful clinical conclusions" about the cases.
FDA staff said they generally agreed with Merck's assessment that boceprevir was effective in treating hepatitis C, a disease that destroys the liver. Analysts project the drug could generate blockbuster sales if approved.
(Reporting by Lisa Richwine, editing by Gerald E. McCormick)
Merck's Hepatitis C Treatment Gets Early Approval
By Brett Chase Apr 25, 2011 1:30 pm
FDA staffers say treatment appears to work against Hepatitis C, a positive early signal for the drug's chance of winning approval.
Merck (MRK) appears to have a good start to a critically important week for its experimental hepatitis C treatment Boceprevir.
A Food and Drug Administration staff report prepared for Wednesday’s advisory panel meeting found that the drug was effective.
Boceprevir is the first of two hepatitis C drugs to be reviewed by a panel of experts who will give their recommendations on whether the drugs should be approved for sale in the US. Boceprevir will be reviewed Wednesday, while Vertex Pharmaceuticals’ (VRTX) telaprevir faces a panel on Thursday. The FDA often follows its experts’ advice for determining approval, labeling and possible follow-up studies of new drugs.
The report, released this morning, “would suggest an approval recommendation from the committee given boceprevir’s overall efficacy profile,” Leerink Swann analyst Seamus Fernandez says.
The staffers did raise some safety concerns, notably an increased risk of anemia in patients treated with boceprevir. But those potential risks are “widely known and recognized” and don’t appear to be “a show stopper,” Fernandez says.
Hepatitis C is a liver-eroding virus that infected millions of Americans (many are unaware). US officials estimate more than 4 million Americans are infected, including 3.2 million chronically. There is a huge unmet need for better treatments, which factors into the FDA’s decision on approval.
While sales would depend on safety labeling, support of prescribing doctors, insurance reimbursement and other factors, each -- if not both -- of the experimental drugs are potential blockbuster products. ..continue reading..
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FDA says Merck drug successfully fights hepatitis
Federal health officials say a highly-anticipated drug to treat hepatitis C made by Merck appears to cure more patients in less time than established drugs that have been used for 20 years. But the agency has questions about how the drug should be combined with older medicines for the maximum effect.
The Food and Drug Administration posted its review of Merck & Co. Inc.'s boceprevir ahead of a public meeting next week to consider whether to approve the medication. The meeting brings to a head more than 15 years of research to find a better therapy for a virus that infects about 3.2 million people in the U.S.
FDA scientists said the two studies submitted by Merck showed patients had undetectable virus levels six months after completing treatment with boceprevir.
FDA Panel Is Set To Review Two New Hepatitis C Drugs
By Thomas Gryta and Peter Loftus
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--A U.S. Food and Drug Administration panel will review two hepatitis C drugs next week, recommending whether regulators should allow the drugs on the market.
The agency's Antiviral Drugs Advisory Committee will review Merck & Co. Inc.'s (MRK) boceprevir on Wednesday and Vertex Pharmaceuticals Inc.'s (VRTX) telaprevir on April 28. Both drugs are widely expected to be recommended for approval, as they have shown strong effectiveness in improving the cure rates in patients that use standard therapy for the liver disease.
But advisory committees are notoriously unpredictable. The briefing documents for the panel, coming from both the companies and FDA staff, will be posted early next week. The documents sometimes show data surprises or previously unknown concerns, and investors will be on the lookout for anything that may translate to a market advantage down the road.
The approval of both drugs, which could come in May, would pit Cambridge, Mass., Vertex against one of the world's biggest drug makers in a market-share battle. Vertex is widely seen as having an advantage, because of more-impressive clinical data, and thus grabbing the majority of usage.
"There is a belief that the efficacy is better," said Kris Jenner, portfolio manager of the T. Rowe Price Health Sciences fund, which owns both Merck and Vertex shares. "There's a general expectation that the market will have a preference for the Vertex compound and I generally agree with that."
Eliav Barr, vice president of Infectious Diseases research at Merck, said that boceprevir "represents a significant improvement over standard therapy" and the company looks forward to presenting data at the panel to support its use.
Camilla Graham, Vertex vice president of Global Medical Affairs, said the company is eager to review the telaprevir data with the committee, "as we know that people are waiting for more effective medicines to treat this curable disease."
Hepatitis C is a blood-transmitted virus that causes liver inflammation and can lead to cirrhosis, cancer and liver failure. The disease affects five million people in the U.S. and more than 200 million people in the world, and is the leading cause of liver transplants in the U.S., according to the Hepatitis C Association.
Both the Merck and Vertex drugs are known as protease inhibitors, which are designed to block an enzyme that helps the hepatitis C virus replicate.
The current standard therapy, a combination of pegylated-interferon injections and ribavirin pills over 48 weeks, achieves a cure in up to about 50% of patients, according to the Centers for Disease Control and Prevention.
Treating the disease is big business. Goldman Sachs recently projected that the total hepatitis C treatment market will grow from its current level of $3 billion to a range of $10 billion to $12 billion following the introduction of the latest batch of drugs. Vertex owns the North American rights to the drug and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ).
Merck is expected to get a decision in early May, while Vertex should get a decision by May 23, but there could be a delay in the rulings because of the proximity to the panel.
The panel is expected to review the data on the drugs, their effectiveness and side effects. With boceprevir being reviewed first, the tone and concerns that are discussed Wednesday could foreshadow the focus of telaprevir's review the next day.
There is likely to also be some discussion of the use of the drugs in patients that haven't responded to prior therapy, as well as the potential for patients to develop resistance to the drugs or future treatments.
Telaprevir has been associated with a rash in some patients, while both drugs have been linked to increased anemia. Unlike telaprevir, the clinical studies of boceprevir included the use of erythropoietin, an anemia treatment sold by Amgen Inc. (AMGN) as Epogen and Johnson & Johnson as Procrit, in order to treat the side effect in some patients.
Merck is currently conducting a study of the safety of erythropoietin when used with boceprevir and its relationship to the drug's effectiveness. Some analysts expect the FDA will want to see that data, expected later this year, prior to approving boceprevir.
Merck has proposed a brand name of Victrelis for boceprevir, while Vertex hasn't yet disclosed its naming plans.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com
The Food and Drug Administration posted its review of Merck & Co. Inc.'s boceprevir ahead of a public meeting next week to consider whether to approve the medication. The meeting brings to a head more than 15 years of research to find a better therapy for a virus that infects about 3.2 million people in the U.S.
FDA scientists said the two studies submitted by Merck showed patients had undetectable virus levels six months after completing treatment with boceprevir.
FDA Panel Is Set To Review Two New Hepatitis C Drugs
By Thomas Gryta and Peter Loftus
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--A U.S. Food and Drug Administration panel will review two hepatitis C drugs next week, recommending whether regulators should allow the drugs on the market.
The agency's Antiviral Drugs Advisory Committee will review Merck & Co. Inc.'s (MRK) boceprevir on Wednesday and Vertex Pharmaceuticals Inc.'s (VRTX) telaprevir on April 28. Both drugs are widely expected to be recommended for approval, as they have shown strong effectiveness in improving the cure rates in patients that use standard therapy for the liver disease.
But advisory committees are notoriously unpredictable. The briefing documents for the panel, coming from both the companies and FDA staff, will be posted early next week. The documents sometimes show data surprises or previously unknown concerns, and investors will be on the lookout for anything that may translate to a market advantage down the road.
The approval of both drugs, which could come in May, would pit Cambridge, Mass., Vertex against one of the world's biggest drug makers in a market-share battle. Vertex is widely seen as having an advantage, because of more-impressive clinical data, and thus grabbing the majority of usage.
"There is a belief that the efficacy is better," said Kris Jenner, portfolio manager of the T. Rowe Price Health Sciences fund, which owns both Merck and Vertex shares. "There's a general expectation that the market will have a preference for the Vertex compound and I generally agree with that."
Eliav Barr, vice president of Infectious Diseases research at Merck, said that boceprevir "represents a significant improvement over standard therapy" and the company looks forward to presenting data at the panel to support its use.
Camilla Graham, Vertex vice president of Global Medical Affairs, said the company is eager to review the telaprevir data with the committee, "as we know that people are waiting for more effective medicines to treat this curable disease."
Hepatitis C is a blood-transmitted virus that causes liver inflammation and can lead to cirrhosis, cancer and liver failure. The disease affects five million people in the U.S. and more than 200 million people in the world, and is the leading cause of liver transplants in the U.S., according to the Hepatitis C Association.
Both the Merck and Vertex drugs are known as protease inhibitors, which are designed to block an enzyme that helps the hepatitis C virus replicate.
The current standard therapy, a combination of pegylated-interferon injections and ribavirin pills over 48 weeks, achieves a cure in up to about 50% of patients, according to the Centers for Disease Control and Prevention.
Treating the disease is big business. Goldman Sachs recently projected that the total hepatitis C treatment market will grow from its current level of $3 billion to a range of $10 billion to $12 billion following the introduction of the latest batch of drugs. Vertex owns the North American rights to the drug and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ).
Merck is expected to get a decision in early May, while Vertex should get a decision by May 23, but there could be a delay in the rulings because of the proximity to the panel.
The panel is expected to review the data on the drugs, their effectiveness and side effects. With boceprevir being reviewed first, the tone and concerns that are discussed Wednesday could foreshadow the focus of telaprevir's review the next day.
There is likely to also be some discussion of the use of the drugs in patients that haven't responded to prior therapy, as well as the potential for patients to develop resistance to the drugs or future treatments.
Telaprevir has been associated with a rash in some patients, while both drugs have been linked to increased anemia. Unlike telaprevir, the clinical studies of boceprevir included the use of erythropoietin, an anemia treatment sold by Amgen Inc. (AMGN) as Epogen and Johnson & Johnson as Procrit, in order to treat the side effect in some patients.
Merck is currently conducting a study of the safety of erythropoietin when used with boceprevir and its relationship to the drug's effectiveness. Some analysts expect the FDA will want to see that data, expected later this year, prior to approving boceprevir.
Merck has proposed a brand name of Victrelis for boceprevir, while Vertex hasn't yet disclosed its naming plans.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com
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