Press release
Savara Awarded Innovation Passport in United Kingdom (UK) for Molgramostim Nebulizer Solution (Molgramostim), a Novel Investigational Inhaled Biologic
Innovation Passport Awarded to Molgramostim for the Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP), a Rare Lung Disease The Innovation
About this update from Savara, Inc.
[{"type":"text","content":"\nInnovation Passport Awarded to Molgramostim for the Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP), a Rare Lung Disease\n\nThe Innovation Passport, a UK Designation for Innovative Medicines, is the Entry Point to the Innovative Licensing and Access Pathway (ILAP), a Program Designed to Accelerate the Time to Market and Facilitate Access to Medicines in the UK\n\nMolgramostim is Being Investigated in a Pivotal Phase 3 Trial, IMPALA-2, for the Treatment of aPAP\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced molgramostim has been awarded an Innovation Passport for the treatment of aPAP by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). 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.\n\nIn 2019, molgramostim was granted Fast Track Designation and Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) 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.\n\n“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,” said Matt Pauls, Chair and CEO, Savara. “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.”\n\nAbout ILAP:\n\nILAP 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 (NICE), and the Scot...