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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.
[Associated
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