EMA’s CHMP Backs Arch Biopartners’ AB569 for Orphan Drug Status

The European Medicines Agency’s Committee for Orphan Medicinal Products has recommended Arch Biopartners’ cystic fibrosis candidate for orphan designation.

Granted orphan status by the FDA in November for the treatment of Pseudomonas aeruginosa pulmonary infections in patients with cystic fibrosis, AB569 has two active ingredients — sodium nitrite and ethylenediaminetetraacetic acid.

The European Commission will review CHMP’s recommendation and is expected to make a final decision on AB569’s orphan status in the next few weeks.