jueves, 16 de noviembre de 2017

Press Announcements > FDA approves treatment for rare genetic enzyme disorder

Press Announcements > FDA approves treatment for rare genetic enzyme disorder

The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA


The U.S. Food and Drug Administration today approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is an extremely rare, progressive condition that affects most tissues and organs.

The most common side effects after treatment with Mepsevii include infusion site reactions, diarrhea, rash and anaphylaxis.

The FDA is requiring the manufacturer to conduct a post-marketing study to evaluate the long-term safety of the product.

For more information, please visit:  Mepsevii

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