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NEWS
Savara Announces Expanded Access Program (EAP) for Molgramostim Inhalation Solution (Molgramostim) for Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Savara Inc. (Nasdaq: SVRA) has announced the Savara Early Access Program, an Expanded Access Program (EAP) for molgramostim inhalation solution to treat patients with autoimmune pulmonary alveolar proteinosis (aPAP). This program allows physicians to request molgramostim for eligible aPAP patients in select regions where the product is not commercially available, in compliance with local regulations.
The EAP has been approved by the U.S. Food and Drug Administration (FDA)and is currently accepting requests from eligible patients in select North American and European countries, with plans to expand through 2026. Savara plans to submit a Biologics License Applicationto the FDA for molgramostim in aPAP in the first half of 2025.
Molgramostim has received Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA, as well as similar designations from European and UK regulatory agencies for the treatment of aPAP.
The EAP has been approved by the U.S. Food and Drug Administration (FDA)and is currently accepting requests from eligible patients in select North American and European countries, with plans to expand through 2026. Savara plans to submit a Biologics License Applicationto the FDA for molgramostim in aPAP in the first half of 2025.
Molgramostim has received Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA, as well as similar designations from European and UK regulatory agencies for the treatment of aPAP.
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