FDA approves Baxalta's drug for rare bleeding disorder

The US Food and Drug Administration said on Friday it approved Baxalta Inc's drug for use in patients with a type of rare bleeding disorder. The drug, Adynovate, was approved to control and reduce the frequency of bleeding episodes in patients with Hemophilia A, the agency said in a statement. Data from a late-stage study, which tested 137 patients, showed that Adynovate was effective in reducing and controlling bleeding episodes, compared with Advate.
Baxalta, which also owns Advate, said the drug is the world's most prescribed hemophilia treatment. Hemophilia is a rare bleeding disorder in which the blood fails to clot normally.