Blue­bird bio may fi­nal­ly get a gene ther­a­py ap­proved in the US

Blue­bird bio may, at long last, get a gene ther­a­py ap­proved in the US.

The Cam­bridge, MA biotech an­nounced Mon­day that the FDA had ac­cept­ed and giv­en pri­or­i­ty re­view for Zyn­te­glo, its gene ther­a­py for the rare blood dis­or­der be­ta-tha­lassemia. The an­nounce­ment sets up an ex­pe­dit­ed FDA de­ci­sion by May 20, 2022.

A pri­or­i­ty re­view doesn’t guar­an­tee ap­proval, and more than a few re­cent biotechs have been spurned af­ter re­ceiv­ing the des­ig­na­tion, in­clud­ing In­cyte, Sesen, and Proven­tion. But it rep­re­sents a sub­stan­tial step for­ward for a ther­a­py that has seen re­peat­ed set­backs and a com­pa­ny that not long ago had an ap­pli­ca­tion slapped down with a refuse-to-file let­ter.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.