Rare And Orphan Disease

The FDA has granted orphan drug designation to AISA-021, a fourth-generation calcium channel blocker, for the treatment of systemic sclerosis, according to a press release from Aisa Pharma.

On Sept. 29, a federal judge dismissed a lawsuit from Catalyst Pharmaceuticals against the FDA and Jacobus Pharmaceuticals over the approval of a rival drug for a rare autoimmune disease — a ruling that disputes the “exclusivity” of the Orphan Drug Act.