Portola Pharmaceuticals Gets a Surprise Present From the FDA

The FDA approved Portola Pharmaceuticals' (NASDAQ: PTLA) first commercial drug, Bevyxxa, in June, but changes to its manufacturing process resulted in the filing of a prior approval supplement (PAS) and, as a result, a delay in Bevyxxa's launch. The FDA had planned to make a decision on Bevyxxa's PAS at the end of November. However, on Nov. 22, it pushed its decision date to Jan. 30. Apparently, it didn't need as much time as it thought. It signed off on the PAS yesterday, clearing the way for Portola Pharmaceuticals to begin selling Bevyxxa in January.

Bevyxxa is a factor Xa anticoagulant approved to prevent venous thromboembolism (VTE) in acutely ill medical patients who are being discharged from hospitals following a serious medical event, such as heart failure, stroke, and infection.

IMAGE SOURCE: GETTY IMAGES.

Continue reading

Source: Fool.com