The U.S. Food and Drug Administration last year accepted the marketing application for the therapy, which is being developed in collaboration with Swedish drugmaker Sobi, and is expected to decide on an approval status by Feb. 28.

Hemophilia A is an inherited bleeding disorder in which the blood does not clot normally. About 400 babies are born with this condition every year, although the exact number of people affected is not known, according to government data.

(Reporting by Khushi Mandowara in Bengaluru; Editing by Sherry Jacob-Phillips)