Gilead Scores Another Hepatitis FDA Approval

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The biotech industry had enjoyed years of growth, but the past year was tarnished on the political election rhetoric about drug pricing. If one company had been at the center of criticism, it was Gilead Sciences Inc. (NASDAQ: GILD) for its high-cost hepatitis C treatments.

Now Gilead has announced that the U.S. Food and Drug Administration (FDA) has approved Vemlidy 25 mg. This is a once-a-day treatment for adults with chronic hepatitis B virus infection with compensated liver disease.

What matters here is that chronic hepatitis B affects up to 2.2 million people in the United States alone. It is a life-threatening illness.

Gilead describes Vemlidy as a novel and targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread 300 mg. Because it has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose. As such, Vemlidy improved renal and bone laboratory safety parameters compared to Viread.

Before investors run blindly into Gilead, they need to consider that Vemlidy comes with a black-box warning label. The company’s press release said:

Vemlidy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B… Vemlidy and Viread were generally well-tolerated by patients in both studies and discontinuations due to adverse events were 1% and 1.2%, respectively.

John Milligan, president and chief executive officer of Gilead, said:

Since the mid-1990s, Gilead has been working to improve and simplify care for people living with chronic hepatitis B. Vemlidy is the first medication approved to treat this disease in nearly a decade, and we are excited to offer a new, effective option to help advance long-term care for patients.

Gilead showed that the most commonly reported adverse events in both of its drug studies included headache, abdominal pain, fatigue, cough, nausea and back pain and occurred at similar rates in patients receiving either Vemlidy or Viread.

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Gilead shares were last seen trading down 1.25% at $77.49 on Thursday in midday trading. Gilead has a 52-week range of $71.39 to $108.63, and its consensus analyst price target from Thomson Reuters was last seen up at $96.51.