LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has unveiled the Savara Early Access Program, a significant initiative aimed at providing molgramostim to patients suffering from autoimmune pulmonary alveolar proteinosis (aPAP). This program allows physicians to request the investigational treatment for eligible aPAP patients in regions where molgramostim is not yet commercially available, adhering to local regulatory standards.
The U.S. Food and Drug Administration (FDA) has reviewed and approved the program, which is now open to requests from qualified patients in select areas across North America and Europe, with plans for broader availability by 2026.
“Expanded access is granted to investigational products that address a serious condition for which there are no comparable therapies available,” stated Matt Pauls, Chair and CEO of Savara. Emphasizing the urgent need for aPAP solutions, Pauls added, “Given the high unmet need in aPAP, and positive results demonstrated in the Phase 3 IMPALA-2 clinical trial, we felt it was critically important to establish the Savara Early Access Program to allow eligible aPAP patients pre-approval access to molgramostim.”
Savara’s commitment extends beyond immediate access, with plans to submit a Biologics License Application for molgramostim to the FDA by mid-2025. The treatment has already received several designations, including Orphan Drug, Fast Track, and Breakthrough Therapy from the FDA, as well as Orphan Drug designation from the European Medicines Agency. Additionally, the UK’s Medicines and Healthcare Products Regulatory Agency has awarded it Innovative Passport and Promising Innovative Medicine status for aPAP treatment.
This initiative reflects Savara’s ongoing dedication to the aPAP community, aiming to deliver an effective therapy for this rare lung disease as swiftly as possible.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.