According to Savara, the MHRA has granted Promising Innovative Medicine (PIM) designation to the company’s molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The PIM designation indicates that the product could be eligible for the UK’s early access to medicines scheme (EAMS). Molgramostim also recently received Innovation Passport designation from the MHRA and was granted Breakthrough Therapy designation by the FDA for the treatment of aPAP in December 2019.
Molgramostim is delivered via PARI‘s eFlow nebulizer system. Savara initiated the IMPALA-2 clinical trial of molgramostim for aPAP in June 2020 after the original Phase 3 IMPALA study of molgramostim for aPAP failed to meet its primary endpoint but showed promise on secondary endpoints.
Savara Chair and CEO Matt Pauls commented, “This PIM designation was granted on the basis of molgramostim nonclinical and clinical data and further reinforces the potential of molgramostim to provide significant benefit in the treatment of aPAP. We look forward to working with the MHRA, on both the Innovation Passport and PIM designations, to advance this program and leverage the potential benefits of the EAMS program.”
Read the Savara press release.
