Press release
Savara Awarded Promising Innovative Medicine (PIM) Designation in the United Kingdom (UK) for Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
PIM Designation Recognizes Molgramostim as a Promising Candidate for the UK Early Access to Medicines Scheme (EAMS) – A Program that Aims to Give Patients
About this update from Savara, Inc.
[{"type":"text","content":"\nPIM Designation Recognizes Molgramostim as a Promising Candidate for the UK Early Access to Medicines Scheme (EAMS) – A Program that Aims to Give Patients with Life Threatening or Seriously Debilitating Conditions with Unmet Medical Need Access to Medicines That Do Not Yet Have Marketing Authorization\n\nMolgramostim, a Novel Investigational Inhaled Biologic, is in Phase 3 Development for the Treatment of aPAP, a Rare Lung Disease\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted Promising Innovative Medicine (PIM) designation to molgramostim for the treatment of aPAP, a rare lung disease with no approved pharmaceutical treatments. PIM designation is an early indication that molgramostim is a promising candidate for the EAMS, a program that provides an opportunity for important therapies to be used in UK clinical practice in parallel with the later stages of the regulatory process. Medicines with a positive scientific opinion could be made available to UK patients 12-18 months before formal marketing authorization is granted.\n\nOn June 15, 2022, molgramostim was awarded Innovation Passport designation by MHRA. In 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“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,” said Matt Pauls, Chair and CEO, Savara. “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.”\n\nAbout PIM Designation:\n\nFor the MHRA to grant a PIM designation, medicinal products must meet the following criteria:\n\n\nThe condition should be life-threatening or seriously debilitating with a high unmet need for which there is no method of treatment, diagnosis or prevention available or where existing ...