It was announced on Friday evening that the FDA has approved Portola Pharmaceuticals’ Andexxa (andexanet alfa), a coagulation agent for uncontrolled bleeding. Portola’s therapy was at first rejected by FDA, due to the cardiovascular risks associated to it. It has now been approved on the sole condition that Portola includes a warning in the product’s box. The treatment has been recently assessed in the Phase III ANNEXA clinical trial, whose results have been published in The New England Journal of Medicine.
Portola’s shares have immediately reacted to the news, rising by over 25%, as HealthCare Royalty Partners–which last August acquired the rights to the drug–is due to pay an upfront $100m to Portola upon approval.