DATA GRAPHICS | Data Byte
Panels to discuss Andexxa’s full approval, medical devices that use generative AI, and the REMS for clozapine
By Gunjan Ohri, Data Content Analyst
November 6, 2024 11:34 PM UTC
FDA has at least three advisory committee meetings coming up in November, including one to review the data supporting full approval of Andexxa from AstraZeneca.
The agency granted accelerated approval to Andexxa andexanet alfa in 2018. The recombinant coagulation factor Xa is indicated for patients receiving rivaroxaban or apixaban who are experiencing life-threatening and uncontrolled bleeding. In the Phase IV ANNEXA-I post marketing trials, which formed the basis of the application seeking conversion to full approval, AstraZeneca plc (LSE:AZN; NASDAQ:AZN) reported that Andexxa achieved superior hemostatic efficacy versus usual care. The recombinant coagulation factor Xa has a boxed warning of thromboembolic risks, ischemic risks, cardiac arrest and sudden death. …
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- Source: https://www.biocentury.com/article/654056/three-fda-advisory-committees-in-november