The FDA has approved a Portola Pharmaceuticals drug that reverses the effect of blood thinners in cases of life-threatening bleeding. The decision comes two years after the regulator rejected the drug due to manufacturing concerns.
The agency still has some concerns about the drug, andexanet alfa (Andexxa). The drug’s label must carry a boxed warning about its cardiovascular risks. In its announcement of the approval late Thursday, South San Francisco, CA-based Portola (NASDAQ: PTLA) said continued approval for the injectable drug may be contingent on post-marketing study results.
But investors welcomed the news, boosting shares of Portola 19 percent to… Read more »
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