Savara’s Early Access Program

Savara’s Early Access Program (EAP) for molgramostim inhalation solution
(molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP).
Molgramostim, an investigational therapy for the treatment of autoimmune PAP, may
be available for eligible patients through Savara’s EAP. IMPALA-2 (Savara’s Phase 3
clinical trial for molgramostim) has completed enrollment, and access to
molgramostim through the EAP is separate from a clinical trial. A biologics license
application (BLA) for molgramostim was submitted to the U.S. Food and Drug
Administration (FDA) in December 2025. Savara’s EAP protocol was reviewed and
allowed to proceed by the FDA in September 2024. The EAP is intended to provide
post-trial access for IMPALA-2 participants who have completed the trial and to
provide pre-approval access to molgramostim for eligible patients with autoimmune
PAP in the United States and specific countries in Europe. Access to molgramostim
through the EAP must be requested by a treating pulmonologist.
Autoimmune PAP is a rare lung disease in which a substance (surfactant) builds up
in the small air sacs (alveoli) of the lungs, making it harder for oxygen to pass into
the bloodstream. People living with autoimmune PAP may experience shortness of
breath, fatigue, cough, and an increased risk of lung infections. In some cases, the
condition can worsen over time and lead to serious lung complications.

Pulmonologists who would like more information about molgramostim or Savara’s
EAP can email [email protected]. Patients interested in learning more
about the EAP should speak with their treating pulmonologist.