Following positive results in a phase IV clinical trial, Astrazeneca is making moves to apply for full approval for its anticoagulant reversal drug Andexxa earlier than expected. Data from the trial, which is being ended early based on outside recommendations, showed that the drug was effective in patients on certain anticoagulants who are experiencing an intracranial hemorrhage.
According to Katherine Lewin, “Andexxa has changed hands multiple times through the years. It first hit the market with an accelerated approval in 2018 when it was owned by Portola Pharmaceuticals, based on Phase III data from healthy volunteers. The California biotech first submitted an NDA for Andexxa in late 2015, only to be caught off guard with an FDA rejection. At the time, the South San Francisco biotech said the agency was looking for more information on manufacturing and how the antidote works in other blood thinning drugs, such as Savaysa (edoxaban) and Lovenox (enoxaparin).”
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(Source: Endpoints News, June 5th, 2023)
