Gilead Gets FDA Approval for Combo Hepatitis C Drug

By Tess Stynes and Jonathan D. Rockoff 

Gilead Sciences Inc. received U.S. Food and Drug Administration approval for its Epclusa hepatitis C combination drug and priced the treatment below its older drugs for the disease.

Shares of the Foster City, Calif., company, which dominates the market for hepatitis C drugs, rose 3.6% to $81.09 in afternoon 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.

Gilead priced Epclusa lower than its older hepatitis C drugs, at $74,760 for a course of treatment before discounts, according to a company spokeswoman.

Gilead has faced ongoing criticism about the high cost of its other two hepatitis C pills, Sovaldi and Harvoni, though the company has been discounting the drugs. Gilead said Epclusa would cost about half of the most commonly used regimen treating patients with genotype 3 of the disease.

In a late-stage 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] and Jonathan D. Rockoff at [e-mail]

(END) Dow Jones Newswires

June 28, 2016 12:47 ET (16:47 GMT)

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