Simeprevir - FDA Advisers Unanimously Back J&J Hepatitis C Drug

FDA Advisers Unanimously Back J&J Hepatitis C Drug


SILVER SPRING, Md. October 24, 2013 (AP)
By MATTHEW PERRONE AP Health Writer

An experimental hepatitis C drug from Johnson & Johnson has won unanimous support from government advisers who say the medication should be approved to treat patients infected with the liver-destroying virus.

All 19 members of the Food and Drug Administration's panel of virus experts voted in favor of approving J&J's simeprevir, a daily pill designed to eliminate the most common form of hepatitis C.

The FDA is not required to follow the group's recommendations, though it often does. A decision on the drug is expected next month.

Roughly 3.2 million people in the U.S. have hepatitis C, a blood-borne disease that causes liver damage and is blamed for 15,000 deaths a year. J&J is one of a half-dozen companies working to develop more effective treatments for the virus as it threatens to become a major health epidemic among baby boomers and middle-age Americans.

"We clearly need better drugs and the evidence is strong that this is a better drug," said panelist Dr. Curt Hagedorn of the Central Arkansas Veterans Healthcare Service.

New Brunswick, N.J.-based J&J is seeking approval to combine its pill with the long-established drug cocktail used to treat the most common form of the virus.

Despite the unanimous vote Thursday, the panel's endorsement came with a number of conditions.

The panelists stressed that the drug is less effective in patients with a common genetic mutation called Q80K, and that people with the abnormality should be screened out so they can receive other drugs. The group also said the drug's label should warn patients and doctors that sunburn is a common side effect. Finally, panelists said that the FDA should require J&J to conduct additional studies of the drug's effectiveness in minorities, especially African-Americans who are disproportionately infected.

"They shouldn't have any trouble finding these patients in the U.S.," said panelist Dr. Marc Ghany of the National Institutes of Health, noting that the company's research has overwhelmingly involved white patients.

The FDA meeting comes as federal health officials urge all baby boomers to get tested for the virus, which can go unnoticed for decades before causing symptoms. People born between 1945 and 1965 are five times more likely to have the virus than people of other age groups. Many of them contracted the virus by sharing needles or having sex with an infected person in their youth. The disease was also spread by blood transfusions before 1992, when blood banks began testing for the virus.

For the last 20 years, the standard treatment for hepatitis C has involved a grueling one-year regimen of pills and injections. These two antiviral drugs, known as ribavirin and interferon-alpha, cause flu-like side effects including nausea, diarrhea and muscle achiness. The introduction of new drugs from Merck and Vertex Pharmaceuticals in 2011 helped shorten the treatment period and boost cure rates as high as 75 percent.

J&J's simeprevir appears to be slightly more effective than the standard of care, curing 80 percent of patients who had not previously been treated for the disease, according to studies submitted to the FDA. More significantly, the drug helped most patients cut the amount of time they had to take the traditional drug cocktail, with its unpleasant side effects, to six months rather than one year. Additionally, panelists said the drug's once-a-day dosage should be far more manageable for patients than the current drugs from Merck and Vertex, which require taking 12 pills or six pills a day, respectively.

"Reducing exposure to interferon and ribavirin is a wonderful thing, especially with a drug that is easier to take than the other options," said Dr. Demetre Daskalakis, associate professor at Mt. Sinai School of Medicine in New York.

On Friday the same panel of experts will review another experimental hepatitis C drug from Gilead Sciences Inc. Many analysts expect the drug, known as sofosbuvir, to become the leading treatment for the disease, based on research showing it cures 90 percent of patients with the most common form of hepatitis C in 12 weeks.

http://abcnews.go.com/Health/wireStory/fda-advisers-unanimously-back-jj-hepatitis-drug-20673544


FDA Advisory Committee recommends approval of Simeprevir for combination treatment of genotype 1 chronic hepatitis C in adult patients

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 19 to 0 to recommend approval of the investigational protease inhibitor simeprevir (TMC435) 150 mg capsules administered once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis. The Advisory Committee recommended the approval of simeprevir based on analyses of data from clinical trials in patients who are treatment-naïve or who have failed previous interferon-based therapy.

”The recommendation from the Advisory Committee is indeed a very positive event for Medivir and we hope that it will lead to a rapid approval of simeprevir by the FDA”, said Maris Hartmanis, Medivir’s CEO.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292.

About Simeprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, for the treatment of genotype 1 and genotype 4 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.

Janssen R&D Ireland, and its affiliated companies, are responsible for the global clinical development of simeprevir and have acquired exclusive, worldwide marketing rights, except for the Nordic countries where Medivir AB have retained the marketing rights under the marketing authorization held by Janssen-Cilag International NV.

Simeprevir was approved in Japan in September 2013 for the treatment of genotype 1 hepatitis C. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials

For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is the focus of a rapidly evolving treatment landscape. Approximately 150 million people are infected with hepatitis C worldwide – including approximately 3.2 million people in the United States – and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir AB, please visit the Company’s website: www.medivir.com
  
Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people’s health and quality of life.