FDA approves Telaprevir Incivek for hepatitis C
Oct 2011
INCIVEK(TM) (telaprevir) Now Available in Canada
Telaprevir/Incivek Prescribing Information
Medication Guide
Patient Assistance Programs
INCIVEK/Telaprevir and VICTRELIS (Boceprevir) Patient Assistance Program
European approval for hepatitis C drug, Telaprevir-Incivek "called Incivo in Europe."
Health Canada Okays INCIVEK For People With Hepatitis C
Also see; Getting Ready; Telaprevir or Boceprevir ?
SILVER SPRING, Md., May 23, 2011 /PRNewswire-USNewswire/ --
The U.S. Food and Drug Administration today approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.
The current standard of care for patients with chronic hepatitis C infection is peginterferon alfa and ribavirin taken for 48 weeks. Less than 50 percent of patients respond to this therapy.
The safety and effectiveness of Incivek was evaluated in three phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy. In all studies patients also received the drug with standard of care. In previously untreated patients, 79 percent of those receiving Incivek experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone.
The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care.
The studies indicate that treatment with Incivek can be shortened from 48 weeks to 24 weeks in most patients. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90 percent.
When a person achieves a sustained virologic response after completing treatment, this suggests that the hepatitis C infection has been cured.
Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocellular carcinoma), and decreased mortality.
"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, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "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."
According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C infection, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.
Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.
People can get HCV in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor or toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.
Incivek is a pill taken three times a day with food. Incivek should be taken for the first 12 weeks in combination with peginterferon alfa and ribavirin. Most people with a good early response to the Incivek combination regimen can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard of care. Incivek is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
The most commonly reported side effects in patients receiving Incivek in combination with peginterferon alfa and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain. Rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.
On May 13, FDA approved Victrelis (boceprevir), another new treatment for chronic hepatitis C, marketed by Merck of Whitehouse Station, N.J.
Incivek is marketed by Cambridge, Mass.-based Vertex Pharmaceuticals.
For more information:
FDA: Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm
FDA: What's New at FDA in Hepatitis
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151488.htm
FDA: Hepatitis C Tests
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125785.htm
CDC: Hepatitis C Information for the Public
http://www.cdc.gov/hepatitis/C/index.htm
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.
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
Oct 2011
INCIVEK(TM) (telaprevir) Now Available in Canada
Telaprevir/Incivek Prescribing Information
Medication Guide
Patient Assistance Programs
INCIVEK/Telaprevir and VICTRELIS (Boceprevir) Patient Assistance Program
European approval for hepatitis C drug, Telaprevir-Incivek "called Incivo in Europe."
Health Canada Okays INCIVEK For People With Hepatitis C
Also see; Getting Ready; Telaprevir or Boceprevir ?
SILVER SPRING, Md., May 23, 2011 /PRNewswire-USNewswire/ --
The U.S. Food and Drug Administration today approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.
The current standard of care for patients with chronic hepatitis C infection is peginterferon alfa and ribavirin taken for 48 weeks. Less than 50 percent of patients respond to this therapy.
The safety and effectiveness of Incivek was evaluated in three phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy. In all studies patients also received the drug with standard of care. In previously untreated patients, 79 percent of those receiving Incivek experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone.
The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care.
The studies indicate that treatment with Incivek can be shortened from 48 weeks to 24 weeks in most patients. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90 percent.
When a person achieves a sustained virologic response after completing treatment, this suggests that the hepatitis C infection has been cured.
Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocellular carcinoma), and decreased mortality.
"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, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "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."
According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C infection, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.
Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.
People can get HCV in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor or toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.
Incivek is a pill taken three times a day with food. Incivek should be taken for the first 12 weeks in combination with peginterferon alfa and ribavirin. Most people with a good early response to the Incivek combination regimen can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard of care. Incivek is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
The most commonly reported side effects in patients receiving Incivek in combination with peginterferon alfa and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain. Rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.
On May 13, FDA approved Victrelis (boceprevir), another new treatment for chronic hepatitis C, marketed by Merck of Whitehouse Station, N.J.
Incivek is marketed by Cambridge, Mass.-based Vertex Pharmaceuticals.
For more information:
FDA: Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm
FDA: What's New at FDA in Hepatitis
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151488.htm
FDA: Hepatitis C Tests
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125785.htm
CDC: Hepatitis C Information for the Public
http://www.cdc.gov/hepatitis/C/index.htm
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.
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
FDA Panel Backs Approval Of Telaprevir For Hepatitis C
April 28 The FDA advisory panel unanimously backed the approval of Vertex Pharmaceuticals proposed hepatitis C-drug telaprevir.
April 27 - VICTRELIS (boceprevir) was unanimously recommended for approval by the FDA Advisory Committee .
The FDA will make the final approval decision expected by May 23.
Watch for the FDA transcripts of both meetings which will be available on the blog 4-8 weeks after the meetings. These transcripts will offer beneficial information on both drugs.
FDA Panel Backs Approval Of Telaprevir For Hepatitis C
By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)-
A Food and Drug Administration panel unanimously backed the approval of Vertex Pharmaceuticals Inc.'s (VRTX) proposed hepatitis C-drug telaprevir, saying it showed strong effectiveness, a day after also endorsing a similar product from Merck & Co. (MRK).
The panel of non-FDA medical experts voted 18-to-0 on a question that asked whether the available data support approval of the telaprevir in combination with other hepatitis C drugs, pegylated interferon and ribavirin. The vote amounts to a recommendation that the agency approve telaprevir. The FDA usually follows the advice of its advisory panels but isn't required to.
Wall Street analysts widely expect FDA to approve telaprevir and Merck's boceprevir as both have demonstrated significant effectiveness in improving the cure rates in patients who use standard therapy for hepatitis C. One panel member called telaprevir "stunning advance" in the treatment of hepatitis C.
Both drugs are known as protease inhibitors and are designed to block an enzyme that helps the hepatitis C virus replicate. Vertex owns the North American rights to the telaprevir and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ).
The approval of the drugs, which could come in May, would pit Cambridge, Mass., Vertex against Merck, one of the world's biggest drugmakers, in a market that could triple to $12 billion after the introduction of the latest batch of drugs, according to Goldman Sachs.
The two main studies Vertex submitted to the FDA in support of telaprevir showed more patients responded to treatment by achieving a so-called sustained virologic response -- essentially a cure -- and in a shorter period of time than current hepatitis-C therapy. A third study looked at extending treatment with a telaprevir-based regimen.
One study that involved previously untreated patients showed 79% of patients receiving telaprevir in addition to current standard treatments of pegylated interferon and ribavirin had a sustained virologic response compared to 46% of patients not receiving telaprevir as part of their treatment regimens. In some cases, patients were successfully treated in a total of 24 weeks rather than the current 48 weeks of hepatitis C therapy.
The agency said the risks of telaprevir were associated with skin reactions, such as rash, and anemia. The agency said such side effects were "common, sometimes severe, and in some cases treatment limiting." Anemia is a decrease in the number of red-blood cells.
Vertex said rashes was managed in most patients with antihistamines and topical corticosteriods. The company said the significantly higher effectiveness of telaprevir. "In all subject categories has the potential to offer many more patients the benefits of eradicating [hepatitis C] and achieving a viral cure," the company said.
Hepatitis C is a liver disease caused by infection with the hepatitis C virus, which is transmitted through contaminated blood. The infection can cause liver failure, liver cancer and is the leading cause of liver transplants, FDA said. About 3.2 million Americans are infected with hepatitis C.
--By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com
(END) Dow Jones Newswires
Source
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