Novo Nordisk’s (NVO) N8-GP, a long-acting factor VIII, for treatment of people with haemophilia A, is at the FDA altar, awaiting the regulatory agency’s decision.The Biologics License Application for N8-GP was submitted to the FDA on February 27, 2018. Although the FDA set no specific date for the decision, it is expected that the decision could be announced on February 27, 2019, based on the review timeline of 10-12 months since the submission of the BLA. The first long-acting haemophilia A drug to get the FDA nod is Biogen’s Eloctate, which was approved in 2014. CSL Behring's Afstyla, Bayer AG’s Kovaltry and Jivi, Shire’s Adynovate, CSLBehring’s Afstyla and Roche’s Hemlibra are some of the other approved long-acting haemophilia A medications.Hemophilia is a rare but serious bleeding disorder. There are two main types - Hemophilia A, caused due to deficiency or dysfunction of clotting protein factor VIII, and Hemophilia B, caused due to deficiency or dysfunction of clotting protein factor IX. The current standard of care requires recurrent intravenous infusions of either plasma-derived or recombinant factor VIII or IX to control and prevent bleeding episodes.Long-acting haemophilia A drugs have several advantages, including reduced injection frequency, increased treatment adherence, and improved clinical outcomes. Long-acting clotting factors also provide an opportunity for improved individualized treatment for hemophilia. (Source: HEMOPHILIA NEWS TODAY).NVO closed Tuesday’s (Jan.29, 2019) trading at $46.65, up 0.54%.