Orphan Drug Designation for IPF Treatment

Amira Pharmaceuticals Inc. April 19 announced that AM152, its lead LPA1 antagonist, had been granted orphan drug designation by the Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis (IPF).

IPF affects the lungs of patients and their ability to breathe, the San Diego-based company said. Currently, there are no FDA-approved therapies for IPF.

Orphan drug designation provides seven years of market exclusivity, access to regulatory support from FDA, potential FDA user fee reductions, and tax credits related to development expenses.