FDA advisers unanimously vote to approve next-generation hepatitis C drug from J&J

SILVER SPRING, Md. – 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 favour 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 per cent.

J&J’s simeprevir appears to be slightly more effective than the standard of care, curing 80 per cent 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 per cent of patients with the most common form of hepatitis C in 12 weeks.