Baxalta Incorporated BXLT announced that the FDA has approved Vonvendi for the on-demand treatment and control of bleeding episodes in adults suffering from von Willebrand disease (VWD). This makes Vonvendi the first and only recombinant von Willebrand factor to be approved for the treatment of VWD.
Vonvendi is expected to hit the U.S. markets in late 2016. Baxalta intends to file regulatory applications for Vonvendi in Europe in 2017 and in other markets around the world.
We are encouraged by the FDA approval of Vonvendi. Per information provided by Baxalta in its press release, VWD is the most common inherited bleeding disorder across the world, affecting up to one in 100 people while the rarest and often most severe form affects one in 1,000,000 people worldwide.
The FDA approval of Vonvendi comes as a major boost for Baxalta’s portfolio, which currently consists of treatments for bleeding episodes in patients with hemophilia like Advate and Feiba among others.
The last few months have been particularly eventful for Baxalta on the regulatory front. The company gained FDA approval for a couple of drugs, namely, Onivyde (metastatic pancreatic cancer) and Adynovate (hemophilia A). We note that Baxalta expects to launch 20 products by 2020. The company is also looking to boost its pipeline through external partnerships and strategic acquisitions.
Baxalta is a Zacks Rank #1 (Strong Buy) stock. Some of the other favorably ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Anika Therapeutics Inc. ANIK and Mylan N.V. MYL.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment