Feb. 23 Quick Takes: FDA approves Sanofi’s once-weekly hemophilia A therapy

Setting up the first in a series of key launches in the coming years for Sanofi (Euronext:SAN; NASDAQ:SNY), FDA approved the company’s once-weekly hemophilia A therapy Altuviiio efanesoctocog alfa. The company is planning a 2H23 regulatory submission in the EU, where partner Swedish Orphan Biovitrum AB (SSE:SOBI) has rights. Altuviiio is a recombinant factor VIII therapy with Fc engineering that extends circulation by adding a region of von Willebrand factor and XTEN polypeptides — a technology from Amunix Pharmaceuticals Inc., which Sanofi acquired in 2021.

CMS is sticking with its national coverage determination on anti-amyloid therapies for Alzheimer’s disease, denying a request from the Alzheimer’s Association to reconsider the NCD now, before any members of the drug class have received full FDA approval. In its response to the Alzheimer’s Association, CMS stated, “There is not yet evidence meeting the criteria for reconsideration.” The agency previously said it would be open to reconsidering the NCD after the first mAb in the drug class converted its accelerated approval to a full approval. The agency reiterated this timeline in its response: “CMS will expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in the NCD, such as evidence that answers the Coverage with Evidence Development (CED) questions or approval by the FDA based upon evidence of clinical benefit.” Eisai Co. Ltd. (Tokyo:4523) has submitted clinical endpoint data to FDA for Leqembi lecanemab; the drug could gain full approval this summer. ...