The US FDA has granted orphan drug status to Ryplazim, an idiopathic pulmonary fibrosis therapy that Prometic Life Sciences is developing.
It’s the second time the FDA has designated a Prometic IPF treatment an orphan drug. The first covered PBI-4050, a treatment for lung tissue scarring.
Only drugs or biological treatments for rare diseases can obtain orphan drug status. The FDA defines a rare disease as one that affects fewer than 200,000 Americans. An orphan designation provides several benefits to the drug’s developer, including tax incentives and potential market exclusivity for seven years after approval.