Bloomberg News

J&J-Medivir Hepatitis C Pill Wins FDA Advisory Panel Backing (1)

October 24, 2013

Johnson & Johnson (JNJ:US) and Medivir’s experimental hepatitis C treatment should be approved, advisers to the U.S. government said, propelling the companies into a position to enter a competitive market for new drugs.

The Food and Drug Administration’s 19-member advisory panel unanimously recommended the therapy, known as simeprevir, be used in combination with other medicines for the most common form of hepatitis C. The FDA, which doesn’t have to follow the panel’s advice, is expected to decide on the drug by Nov. 27.

J&J, Medivir, Gilead Sciences Inc. (GILD:US) and AbbVie Inc. (ABBV:US) are among companies developing new pills for hepatitis C to alleviate the burden of current treatments, including interferon injections, which can cause flu-like symptoms. The market for hepatitis C drugs may reach more than $100 billion over a decade, according to Bloomberg Industries. Advisers tomorrow will consider a hepatitis C therapy from Gilead.

“As someone who treats patients with chronic hepatitis C every day, I think this regimen represents a much safer one and a much simpler one than what’s currently existing,” Marc Ghany, a panel member and physician in the liver diseases branch of the National Institute of Diabetes, Digestive and Kidney Diseases, said after the vote.

The panel discussed a recommendation made by FDA staff and supported by J&J, based in New Brunswick, New Jersey, to screen potential simeprevir patients for a genetic mutation called Q80K polymorphism that renders the drug ineffective.

Genetic Defect

The Q80K polymorphism was found in 48 percent of U.S. patients with a genotype 1a hepatitis C infection in clinical trials compared with 19 percent of patients in Europe, J&J said. The mutation is almost nonexistent in those with a genotype 1b infection.

A study of an all-oral combination of simeprevir with Gilead’s sofosbuvir has shown that the regimen mitigates the effect Q80K has on simeprevir, Gaston Picchio, hepatitis disease area leader at J&J’s Janssen unit, said during the meeting.

Data from the study is expected to be released in November at the American Association for the Study of Liver Diseases’ annual conference in Washington.

J&J, the world’s biggest seller (JNJ:US) of health-care products, and Medivir, based in Huddinge, Sweden, are seeking approval for their once-daily pill to treat chronic hepatitis C patients with the genotype 1 infection. About 70 percent of U.S. patients have the genotype 1 form of the disease. Hepatitis C is divided into 6 genotypes.

Patient Population

About 4 million Americans have the disease, which can cause liver cirrhosis, according to the National Institutes of Health. Hepatitis C can be passed through infected blood or body fluids, most commonly through needle-sharing by drug users.

Treatment for patients now includes interferon and a pill called ribavirin. Most patients take the combination with Merck & Co.’s Victrelis or Vertex Pharmaceuticals Inc. (VRTX:US)’s Incivek for as long as 48 weeks. Simeprevir is in a class of drugs called protease inhibitors that also include Victrelis and Incivek.

Clinical trials found simeprevir can reduce treatment time in half to 24 weeks. The medicine cured about 80 percent of patients who hadn’t been treated before compared with 50 percent of those who took pegylated interferon and ribavirin. Seventy-nine percent of simeprevir users who failed other treatments were cured compared with 37 percent who took only the older drugs, according to J&J.

The most common major side effects of simeprevir were rash and photosensitivity. Panel members agreed with the FDA that the prescribing information for the drug should include a recommendation for patients to use sun protection and avoid tanning beds.

The drug from Foster City, California-based Gilead that advisers will weigh tomorrow, sofosbuvir, may be the first to market in a new class of drugs called nucleotide polymerase inhibitors. Sofosbuvir is effective across all genotypes and can shrink treatment time to 12 weeks.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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Companies Mentioned

  • JNJ
    (Johnson & Johnson)
    • $104.59 USD
    • 0.31
    • 0.3%
  • GILD
    (Gilead Sciences Inc)
    • $91.29 USD
    • 1.84
    • 2.02%
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