CTGTAC Announces November Meeting

Members of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will meet from 10 a.m. to 4 p.m. ET on Nov. 21 to discuss AstraZeneca’s supplemental biologics license application (sBLA) for Andexxa, a recombinant coagulation factor Xa, inactivated -zhzo. The application seeks to expand the use of Andexxa for patients treated with rivaroxaban or apixaban who require anticoagulation reversal due to life-threatening or uncontrolled bleeding.

The public will have an opportunity to present their views to the CTGTAC during the meeting’s public comment session or by submitting written comments. Instructions are available online. 

The Food and Drug Administration will provide background materials no later than two business days before the meeting. The public may watch the meeting via webcast.