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Gilead Sciences Inc. Message Board

  • ibexx ibexx Oct 22, 2013 3:03 PM Flag

    WashingtonPost: FDA to review 2 drugs for hepatitis C as virus becomes health concern for baby boomers

    ""J&J’s simeprevir cured 80 percent of patients who had not previously been treated for the disease, according to the FDA. Additionally, the vast majority of patients were able to cut their treatment time in half to 24 weeks, compared with the usual 52 weeks. The New Brunswick, N.J., company is seeking approval to combine the daily pill with the standard treatment regimen for patients with the most common form of the virus. J&J developed the drug with Swedish drugmaker Medivir.

    On Friday, the same FDA panel will review another hepatitis C drug from Gilead Sciences Inc. that some analysts think will become the first-choice for treating the disease. The pill, known as sofosbuvir, has shown cure rates up to 90 percent after just 12 weeks in some company studies. Additionally, analysts believe the drug will eventually be used without interferon, the injectable medication used in the standard drug cocktail that causes nausea, diarrhea and other unpleasant side effects.

    Gilead is racing against other drugmakers to develop the first all-pill therapy for hepatitis C, long viewed as the holy grail of treatment options by drugmakers. Similar efforts are underway from Abbott Laboratories and Bristol-Myers Squibb Co., among others.

    Pharmaceutical industry consulting firm Decision Resources estimates the market for hepatitis C drugs will grow to more than $23 billion by 2018. Sales of the drugs are expected to decline to $17.5 billion by 2021 as more patients are cured of the virus, according to a report.
    FDA's pre-meeting summary for JNJ drug is already posted on its website. I would say the "tone" is only ukewarm.

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