17 June 2022 - - US-based clinical stage biopharmaceutical company Savara Inc's (NASDAQ: SVRA) molgramostim has been awarded an Innovation Passport for the treatment of aPAP by the UK's Medicines and Healthcare Products Regulatory Agency, the company said.

Innovation Passport is the entry point to the ILAP, a novel program aimed at accelerating the time to market and facilitating patient access to medicines in the UK.

In 2019, molgramostim was granted Fast Track Designation and Breakthrough Therapy Designation by the US Food and Drug Administration for the treatment of aPAP, and in 2012 and 2013 was granted Orphan Drug Designation for the treatment of aPAP in the United States and European Union, respectively.

ILAP was launched in January 2021 as part of the UK's plan to attract life sciences development in the post-Brexit era.

The pathway provides a single integrated platform for sustained collaborative working between the developer of the investigational medicine, the MHRA and its health technology assessment partners, including the All Wales Therapeutics and Toxicology Centre, National Institute for Health and Care Excellence, and the Scottish Medicines Consortium.

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases.

Its lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis.

Molgramostim is delivered via an investigational eFlow Nebulizer System (PARI Pharma GmbH).

The company's management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization.