Posted by Michael Wonder on 26 Sep 2017
FDA approves Grifols Prolastin-C liquid [alpha-1 proteinase inhibitor, liquid] for the treatment of alpha-1 anti-trypsin deficiency
22 September 2017 - Prolastin-C Liquid is the first liquid formulation of an alpha-1 anti-trypsin deficiency replacement therapy manufactured in the U.S. The new formulation marks an important milestone in Grifols' ongoing R&D efforts.
Grifols announced the approval from the U.S. FDA for a liquid formulation of its alpha-1 antitrypsin (Prolastin-C liquid) as a replacement therapy to treat alpha-1 anti-trypsin deficiency (AATD). AATD is a rare genetic disorder that affects approximately 25 per 100,000 people which can lead to pulmonary emphysema without adequate treatment. Moreover, it represents the most common cause of liver disease in children.
The FDA approval culminates an important R&D milestone for Grifols to create a new product formulation of alpha-1 anti-trypsin. The approval process for the product has also commenced in Europe.
