UPDATED: Gilead snags FDA approval for improved hep B drug Vemlidy

Gilead Sciences, whose hepatitis C dynasty has been slipping, has won approval for its next-gen hepatitis B treatment. 

The Foster City, CA-based drugmaker said Thursday that the FDA had approved Vemlidy, a once-daily treatment for adults with chronic hepatitis B virus (HBV) with compensated liver disease. The drug, however, comes with a black-box warning for risks.  

Gilead ($GILD) already has a hep B treatment, Viread, but said today that the new drug can be given at one-tenth the dose of Viread and so has better renal and bone laboratory safety parameters than its predecessor.

Dr. Calvin Pan, a clinical professor of medicine at NYU Langone Medical Center and an investigator in the Vemlidy clinical trials, said the improved renal and bone safety parameters were an important development for the 2.2 million people in the U.S. suffering from the life-threatening disease.

The approval comes at a time when Gilead’s one-time powerhouse hep C treatments Sovaldi and Harvoni have fallen victim to competition and payer discounting, with sales plummeting 31% for the last quarter. The results missed consensus estimates by 3%, even with help from the recent rollout of Epclusa, a regimen that spans all hep C genotypes.

Investors are still looking for Gilead to buy something significant that can pull it out of the dive, as it did when it acquired the asset that turned into Sovaldi and Harvoni. It was rumored to be looking at cancer biotech Medivation, but blocked folks from the deal with a $14 billion bid.

CEO John Milligan told investors that the company is “currently very, very active” in looking for M&A deals but will only “do things when they make sense for us and not before then.”

Editor's Note: The story was updated with information about the EU's CHMP recommending Vemlidy. 

Suggested Articles

In previously untreated nonsquamous NSCLC, a Tyvyt-chemo combo beat chemo alone at stalling the time to tumor progression or death.

It’s been a big year for Bristol's Opdivo-Yervoy combo in lung cancer, but with new mesothelioma data in hand, the duo isn’t done making headlines.

A third spinal muscular atrophy treatment option is set to debut with the FDA’s approval for Roche’s Evrysdi, formerly known as risdiplam.