Prior to this approval, the company only offered Prolastin-C in a lyophilized format. The new formulation requires less preparation time and volume for infusion, according to Barcelona-based Grifols.
The company touted its product as the first liquid formulation of an alpha-1 antitrypsin deficiency replacement therapy made in the U.S. Prolastin-C Liquid will also be manufactured in Spain, Grifols reported in a regulatory filing.
The commercial launch for the new liquid formulation is scheduled for next year. The company is also looking to get its product approved in Europe.
Earlier this month, the European Medicine Agency’s Committee for Medicinal Products for Human Use recommended approval for Grifol’s VeraSeal product.
The biological sealant, made up of fibrinogen and human thrombin, is designed to accelerate the healing process following surgical operations in adults.
GRFS shares were trading at $20.90 apiece in mid-morning activity today, up 0.7%.