MOLBREEVI (molgramostim) inhalation solution
Autoimmune pulmonary alveolar proteinosis · Patients with autoimmune pulmonary alveolar proteinosis
SVRA · Savara, Inc.
Regulatory designations
Full timeline
5 milestonesFDA decision expected after review extension
FDA extended the PDUFA target action date by three months to November 22, 2026.
Savara — PDUFA review extension↗Long-term IMPALA-2 extension data were presented
Open-label extension results showed continued improvement after longer exposure and improvement among participants who switched from placebo to molgramostim.
Savara — Long-term IMPALA-2 extension results↗FDA extended the review after a major amendment
FDA determined that Savara's responses to information requests constituted a major amendment; the agency did not cite safety, efficacy or manufacturing concerns in the extension notice.
Savara — PDUFA review extension↗FDA filed the BLA with Priority Review
FDA accepted the application, assigned the original August 22, 2026 action date and indicated that it did not plan an advisory committee meeting.
Savara — BLA filing and original PDUFA date↗Related News
Savara Provides Update on IMPALA and AVAIL Pivotal Clinical Studies
Dec 19, 2018Savara Announces Interim Results for OPTIMA Clinical Study of Molgradex for the Treatment of NTM
Nov 16, 2018Savara to Present at the Evercore ISI HealthCONx Conference on Tuesday, November 27th
Nov 7, 2018Savara Reports Third Quarter 2018 Financial Results and Provides Business Update
Oct 31, 2018Savara Completes Enrollment in Molgradex OPTIMA Clinical Study for the Treatment of NTM