Molbreevi (molgramostim) for Autoimmune pulmonary alveolar proteinosis
The FDA is expected to decide on Molbreevi for Autoimmune pulmonary alveolar proteinosis by November 22, 2026, under a BLA from Savara.
What is being decided
Savara has a BLA under FDA review for Molbreevi (molgramostim) in Autoimmune pulmonary alveolar proteinosis. Inhaled therapy; review period extended by 3 months.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
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Frequently asked questions
When will the FDA decide on Molbreevi?
The FDA's target decision date (PDUFA date) for Molbreevi in Autoimmune pulmonary alveolar proteinosis is November 22, 2026, disclosed by Savara. The agency can act before this date and occasionally runs past it.
What is Molbreevi being reviewed for?
Savara submitted a BLA for Molbreevi in Autoimmune pulmonary alveolar proteinosis. Inhaled therapy; review period extended by 3 months.
What happens after the Molbreevi decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Savara press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified weekly.