- Gilead got the green light from the Food and Drug Administration Tuesday afternoon for its once-daily, three-drug combination pill for patients with chronic hepatitis C with genotypes one through six that have been treated with an NS5A-containing regimen.
- Vosevi is a combination of the previously approved Sovaldi (sofosbuvir) and velpatasvir, as well as the previously unapproved voxilaprevir.
- Vosevi is the fourth in Gilead’s arsenal of Sovaldi-based HCV treatments. The company said nearly 1.4 million patients have been treated with the therapies so far.
While Gilead Sciences has had great success with its Sovaldi-containing regimens, sales of the drugs have been waning due to the cure rates for patients.
Vosevi gives the big biotech one more way to capitalize on its best-selling drug and expand its lifecycle even as the company shifts gears to other liver diseases.
"Direct-acting antiviral regimens have transformed HCV treatment and have allowed health care providers the fortunate opportunity to cure many patients. However, for patients who require re-treatment, there remains an unmet clinical need for an effective and well-tolerated option," said Ira Jacobson, chairman of the Department of Medicine at Mount Sinai Beth Israel and a principal investigator in the Vosevi clinical trials.
Gilead expects to bring in about $7.5 billion to $9 billion in sales for Sovaldi and Harvoni this year, down from the $14 billion the two drug brought in during 2016.
The approval of Vosevi was based on the two Phase 3 POLARIS-1 and POLARIS-4 studies. Across the two studies, 96% of patients achieved undetectable levels of viral load after 12 weeks of treatment. The label for the drug includes a black box warning that notes patients that also have hep B are at risk of hep B reactivation.