Molgramostim Inhalation Solution

A Japanese registry reported a minimum incidence of 0.49 per million and prevalence of 6.2 per million for autoimmune pulmonary alveolar proteinosis. Reported symptoms include shortness of breath, cough, fatigue, and reduced exercise capacity. In a retrospective cohort of 104 participants with autoimmune pulmonary alveolar proteinosis, 35 (34%) were hospitalized because of infection.

IMPALA-2 randomized 164 participants, 81 to molgramostim and 83 to placebo. At week 24, the reported change in DLCO percent predicted was 9.8% with molgramostim and 3.8% with placebo, an estimated treatment difference of 6.0 percentage points (P<0.001). The SGRQ Total Score comparison had P=0.0072; the SGRQ Activity Score comparison had nominal P=0.0149 but was not statistically significant under the prespecified testing hierarchy. In the 48-week safety report, symptomatic COVID-19 infection occurred in 22% versus 10% and diarrhea in 11% versus 2%, respectively. No deaths were reported.

No product-specific budget impact model is included in this report. The Dutch horizon scan gives an expected annual cost per patient of €100,000–500,000. This is a horizon-scan estimate, not an observed U.S. average sales price or an announced U.S. wholesale acquisition cost.

The phase 3 evidence supports an effect on pulmonary gas transfer at 24 weeks. Savara’s August 2026 update continued to identify MOLBREEVI as unapproved, with regulatory applications under review. The reported November 22, 2026 FDA target action date is not an approval date. The clinical results and the available horizon-scan cost estimate do not establish a product-specific budget impact.