Molbreevi (molgramostim) for Autoimmune pulmonary alveolar proteinosis
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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.
About the drug
Molbreevi: inhaled recombinant human GM-CSF that restores the signal alveolar macrophages need to clear surfactant from the lungs. Our full Molbreevi profile covers how it works, side effects in plain language, and its trial history.
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.
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Pulmonary Alveolar Proteinosis. Unsubscribe anytime.
Frequently asked questions
When will the FDA decide on Molbreevi?
The FDA's target date (PDUFA date) for Molbreevi in Autoimmune pulmonary alveolar proteinosis is November 22, 2026.
Who disclosed it: Savara. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Savara press release
What is Molbreevi being reviewed for?
Savara submitted a BLA for Molbreevi in Autoimmune pulmonary alveolar proteinosis.
What to know: Inhaled therapy; review period extended by 3 months.
How it works: Inhaled recombinant human GM-CSF that restores the signal alveolar macrophages need to clear surfactant from the lungs.
More: the Molbreevi drug page explains it in plain language.
What did the Molbreevi trials show?
IMPALA-2 (NCT04544293) was a Phase 3, double-blind, placebo-controlled trial at 43 sites in 16 countries that randomized 164 adults with autoimmune PAP to inhaled molgramostim 300 micrograms or placebo once daily for 48 weeks; 81 received molgramostim and 83 placebo, with Japan, the United States, Turkey, South Korea and Germany the largest enrolling countries. The primary endpoint was the change at week 24 in DLCO, a breathing test of how well gas crosses from the lungs into the blood.
More: the Molbreevi drug page has the full trial history and sources.
What are the side effects of Molbreevi?
In the 48-week placebo-controlled part of IMPALA-2, the share of patients with at least 1 adverse event and with at least 1 serious adverse event was similar in the molgramostim and placebo groups, and no deaths occurred. Savara's patient summary lists cough and fever as the most common adverse events in people taking molgramostim.
More: the Molbreevi drug page lists the warnings in full.
How much will Molbreevi cost?
Savara has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Molbreevi decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
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 daily.