FDA issues positive review for Gilead's hep C drug

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Associated Press

Posted on October 23, 2013 at 10:00 AM

Updated Wednesday, Oct 23 at 11:02 AM

WASHINGTON (AP) — The Food and Drug Administration issued a positive review Wednesday for a highly anticipated hepatitis C drug from Gilead Sciences, saying the pill cures more patients in less time than currently available treatments.

The agency posted its review of Gilead's sofosbuvir online ahead of a meeting Friday where government experts will vote on whether to recommend the drug's approval.

Between 3 million and 4 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. The drugs currently used to treat the virus cure about three-quarters of people and can take up to a year of treatment.

FDA said adding Gilead's sofosbuvir to the standard drug cocktail cured 90 percent of patients with the most common form of the virus in just 12 weeks.

The agency's reviewers state that the "shorter 12-week duration translates into a better tolerated side effect profile," adding that "no major safety issues associated with sofosbuvir have been identified to date."

Foster City, Calif.-based Gilead Sciences is one of a half-dozen companies working to develop more effective treatments for hepatitis C, and many analysts predict the company's drug will eventually outperform its competitors. The FDA is expected to make a decision on the drug by Dec. 8.

Drugmakers see hepatitis treatments as a potentially lucrative market because the disease is expected to grow into a major public health problem as the baby boom generation ages. People born between 1945 and 1965 are five times more likely to have the virus than people of other age groups, and the Centers for Disease Control and Prevention is urging all baby boomers to get tested for the disease. Many Americans contracted the virus by sharing needles or having sex with an infected person in their youth.

For most of the last 20 years, the standard treatment for hepatitis C has involved a grueling one-year regimen of pills and injections that causes flu-like symptoms and cures less than half of patients. Then in 2011, the FDA approved two new drugs from Merck and Vertex Pharmaceuticals that raised the cure rate to about 65 and 75 percent, respectively, when combined with the older treatments.

Gilead's once-a-day pill appears to push the cure rate even higher.

In a company study of 327 patients with the most common form of the disease, 90 percent of participants had undetectable levels of the virus after 12 weeks of treatment. The form of the disease studied in the trial accounts for about 75 percent of hepatitis C cases in the U.S.

Gilead's drug was not as effective in treating two less common forms of the disease that account for about 25 percent of cases in the U.S. Among those patients, sofosbuvir cured about 67 percent of patients who had not previously taken other hepatitis C drugs.

But even for those patients, the FDA says Gilead's drug represents an important step forward.

The company's approach used only pill-based medications — sofosbuvir and another antiviral drug — while excluding interferon, the injectable medication that is the backbone of standard treatment, which can cause nausea, diarrhea and other unpleasant side effects.

For patients with the less common subtypes of the disease, Gilead's approach "provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile," according to the FDA's review.

Gilead is racing against other drugmakers to develop the first all-pill approach to treating the most common form of hepatitis C, long viewed as the holy grail of treatments by drugmakers. Similar efforts are underway from Abbott Laboratories, Bristol-Myers Squibb Co., Vertex Pharmaceuticals and others.

Citi analyst Yaron Weber said the FDA's review was "overall favorable and may potentially lead to a broad label" for Gilead's drug. He predicts the drug could reach annual sales of $2.74 billion.

Pharmaceutical industry consulting firm Decision Resources estimates the total 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.

Shares of Gilead Sciences Inc. rose 87 cents to $68.96 in midday trading.

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