Gilead Sciences, Inc. (NASDAQ:GILD) traded higher after the Food and Drug Administration (FDA) approved its hepatitis C drug, Vosevi, for patients who have failed to respond to other treatments. The approval is based on two late stage studies POLARIS-1 and POLARIS-4, which evaluated the drug in patients who have already taken Sovaldi among other treatments.
The approval follows the Committee for Medicinal Products for Human Use adopting a positive opinion on the drug last month. The European Commission is poised to review the recommendation for approval in the region.
“Treatment with Vosevi resulted in high cure rates in clinical studies of patients who were not previously cured with several widely-prescribed DAA regimens and will provide physicians with an important new therapeutic option that could offer hope for their hardest-to-treat patients,” said Ira Jacobson, Vosevi Principal Investigator.
However, Vosevi has not been given a clean bill of health given that its usage poses the risk of Hepatitis B reactivation in HCV/HBV co-infected patients. Some of the other adverse events reported with the use of the drug include headaches, fatigue, diarrhea, and nausea.
Declining HCV Sales
Vosevi approval further strengthens Gilead portfolio in the HCV market where it is currently targeting sales with Sovaldi and Harvoni. Sovaldi remains the company’s prized assets in the HCV marketplace even with the expansion of Harvoni uses in the US.
Gilead is under immense pressure to come up with new drugs as competition and price wars continue to affect its revenue streams. Declining new patient’s starts have significantly affected sales for Harvoni. Sovaldi and Epclusa, on the other hand, have come under immense pressure from AbbVie Inc. (NYSE:ABBV) Viekira XR and Bristol-Myers Squibb Co (NYSE:BMY) BMY Daklinza.
The pharmaceutical company has already warned that it expects a further decline in revenue this year due to a decline in HCV patient’s starts fueled by stiff competition. First quarter sales for Hepatitis C drugs slumped to $2.6 billion from $4.3 billion a year earlier.
