Hepatitis C patients should be screened for a genetic mutation called Q80K polymorphism that causes the simeprevir drug not to work as well, Food and Drug Administration workers also said in the review today ahead of an Oct. 24 meeting of agency advisers to discuss the medicine. People with the mutation should seek other therapies, the report said. J&J agreed with the recommendation in the New Brunswick, New Jersey-based company’s meeting document also released today.
The FDA asked its advisers to review simeprevir and Gilead Sciences Inc. (GILD)’s hepatitis C therapy sofosbuvir this week. The market for the new pills may reach more than $100 billion over a decade, according to Bloomberg Industries. The screening requirement may prove positive for Gilead because sofosbuvir isn’t expected to need such a distinction between patients, Brian Abrahams, an analyst with Wells Fargo & Co., said.
Today’s FDA report reaffirms Wells Fargo’s position “that sofosbuvir-based regimens will be the market leaders in 2014 and beyond,” Abrahams wrote in a note to clients today.
The regulatory agency is scheduled to decide whether to approve simeprevir for sale by Nov. 27.
Medivir, based in Huddinge, Sweden, fell 10 percent to 99.25 kronor at close of trading in Stockholm. J&J rose 1.3 percent to $92.36 in New York. Gilead, based in Foster City, California, rose 1.6 percent to $68.09.
J&J and Medivir are seeking approval for their once-daily pill to treat chronic hepatitis C patients with the genotype 1 infection, the most common form of the condition, who have liver disease and haven’t been treated before or who have failed interferons. The disease can lead to a liver transplant.
The Q80K is a “known mutation for simeprevir,” Robyn Karnauskas, an analyst with Deutsche Bank AG, said in a note to clients today.
The Q80K polymorphism was found in 48 percent of U.S. patients with a genotype 1a infection in clinical trials compared with 19 percent of patients in Europe, J&J said in its document. The mutation is almost nonexistent in those with a genotype 1b infection.
Hepatitis C is classified into six genotypes with multiple subtypes such as genotype 1a and genotype 1b. Genotypes 1a and 1b make up 60 percent of global hepatitis C infections, with 1a accounting for as many as 70 percent of patients in North America, J&J said.
Treatment for hepatitis C patients now includes an injected medicine call interferon, which can cause flu-like symptoms. About 4 million Americans have the disease, which can cause liver cirrhosis, according to the National Institutes of Health. The disease can be passed through infected blood or body fluids, most commonly through needle-sharing by drug users.
The major side effect identified with simeprevir was rash and sensitivity to light, FDA workers said.
Patients now are treated with pegylated interferon and ribavirin, a pill, combined with Merck & Co.’s Victrelis or Vertex Pharmaceuticals Inc. (VRTX)’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 about 80 percent of patients on simeprevir in combination with interferon and ribavirin who had never been treated before had undetectable levels of hepatitis C in the blood 12 weeks after discontinuing treatment, compared with 50 percent who took only pegylated interferon and ribavirin. Seventy-nine percent of treatment-experienced patients had undetectable levels after 12 weeks compared with 37 percent of patients who took only the older drugs, according to J&J, the world’s biggest seller of health-care products.
Clinical trials found that simeprevir reduced treatment time in half to 24 weeks for patients with genotype 1 hepatitis C. Gilead’s sofosbuvir may shrink the treatment time for those patients to 12 weeks and would eliminate the need for an interferon injection for other patients.
“Convenience for the patients results in better adherence and better adherence usually results in more efficacy,” said Gaston Picchio, hepatitis disease area leader at J&J’s Janssen unit.
The companies are competing with AbbVie Inc. (ABBV), Bristol-Myers Squibb Co. and Vertex, among others, to bring patients all-oral treatments. J&J will study interferon-free combinations of simeprevir with an investigational drug acquired earlier this year from GlaxoSmithKline Plc. (GSK)
“We’re’re going through a period where we’re all learning,” Picchio said. “The ultimate goal is to come up with the best possible regimen for patients.”
Data from a mid-stage study on a combination of simeprevir and Gilead’s sofosbuvir with or without ribavirin are expected to be released in early November at the American Association for the Study of Liver Diseases’ annual conference in Washington, D.C.
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