FDA Awards Arch Biopartners Orphan Drug Designation for AB569

The FDA has awarded orphan drug designation to Arch Biopartners’ AB569 for the treatment of Pseudomonas aeruginosa pulmonary infections in patients with cystic fibrosis.

The orphan drug designation covers the combination of the nebulized therapy’s two active ingredients, sodium nitrite and ethylenediaminetetraacetic acid.  The company is finalizing the manufacturing and toxicology requirements for AB569 to prepare an IND application.