REMS sans registry may get one

In backing the approval of InterMune's pirfenidone for idiopathic pulmonary fibrosis, an FDA panel voted that the drug's safety had been adequately assessed, despite some concerns. Panelists urged InterMune to track long-term safety data via a patient registry, an item missing from the company's proposed risk evaluation and mitigation strategy. InterMune says it's open to whatever the FDA deems necessary in its final decision-making. Article

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.