Evicenter
P&T meetings

Molgramostim Inhalation Solution

Autoimmune pulmonary alveolar proteinosis

Manufacturer
Savara
Regulatory submission
BLA resubmitted December 2025
Launch
Not announced
Last updated
89 sources

Executive summary

Conclusions

1 evidence topic · 4 sources

Summary

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.