Grifols has announced that its inhaled alpha1-proteinase inhibitor received orphan drug designation from the FDA in April 2012 and that the company will begin a safety study of the drug by the end of the year. Grifols markets intravenous alpha1-proteinase inhibitor, derived from human plasma, as Prolastin-C as a treatment for alpha1-antitrypsin (AAT) deficiency and is developing the inhaled formulation as a treatment for cystic fibrosis.
“Grifols is committed to developing new therapies that address the debilitating symptoms of chronic lung disease. The orphan drug designation represents another milestone in the growth of our alpha1 program, and we’re excited to pursue clinical trials with an aerosol formulation of this important therapy,” said Grifols VP of Clinical Research Development Kim Hanna.
Read the Grifols press release.
