Savara announced that the UK Medicines and Healthcare Products Regulatory Agency has awarded an Innovation Passport to molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The Innovation Passport provides entry into the agency’s Innovative Licensing and Access Pathway (ILAP), which was launched in 2021 to speed approval for selected medications.
The company acquired molgramostim (formerly Molgradex) when it acquired Serendex in 2016. Molgramostim had previously been awarded Orphan Drug designation for the treatment of aPAP in both the US and EU. The FDA granted Fast Track designation to molgramostim in May 2019, and the inhalation solution was granted Breakthrough Therapy designation by the agency for the treatment of aPAP in December 2019, shortly after the FDA recommended against submission of a biologics license application (BLA) submission for molgramostim.
Savara Chair and CEO Matt Pauls said, “Receiving this designation is an important step in the molgramostim regulatory strategy and has the potential to help aPAP patients in the UK gain faster access to this novel inhaled biologic. This most recent designation, MHRA’s Innovation Passport, in addition to Fast Track, Breakthrough Therapy and Orphan Drug designations, recognize aPAP as a seriously debilitating condition in need of a pharmaceutical treatment option—potentially an option like molgramostim. We look forward to working closely with the MHRA, and other regulators, to advance the molgramostim development program.”
Read the Savara press release.
