Gilead Gets FDA Approval for Combo Hepatitis C Drug

Gilead Sciences Inc. received U.S. Food and Drug Administration approval for its Epclusa hepatitis C combination drug, which can be used to treat a wider range of patients.

Shares of the Foster City, Calif., company, which dominates the market for hepatitis C drugs, rose nearly 4% to $81.35 in recent trading in New York.

The new drug, a combination of the biopharmaceutical company's Sovaldi with its new velpatasvir therapy, is the first drug that treats all six major strains of the disease. Pricing information on the drug wasn't immediately available.

In a Phase III study, between 95% and 99% of patients receiving Epclusa had no virus detected in the blood 12 weeks after finishing treatment.

The FDA had granted a priority review of Epclusa early this year. The treatment also had been given FDA breakthrough therapy designation, which is granted to experimental medicines that may offer major advances over existing options.

Gilead had been known for its HIV/AIDS treatments. However, recently the company has seen its sales driven by hepatitis C drugs Harvoni and Sovaldi. The two drugs generated combined sales of $19.14 billion in 2015, an increase of 54% from 2014.

However, in April, Gilead reported that sales of its hepatitis C drugs fell 5.6%, with sales of Harvoni and Sovaldi missing expectations amid growing competition.

Write to Tess Stynes at [e-mail]

(END) Dow Jones Newswires

June 28, 2016 11:35 ET (15:35 GMT)

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