Press release
Insmed Receives Priority Medicines (PRIME) Designation from European Medicines Agency (EMA) for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFBE)
BRIDGEWATER, N.J., Nov. 13, 2020 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of
About this update from Insmed Incorporated
[{"type":"text","content":"BRIDGEWATER, N.J., Nov. 13, 2020 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to brensocatib for the treatment of non-cystic fibrosis bronchiectasis (NCFBE). Brensocatib is a novel, first-in-class, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of NCFBE and other inflammatory diseases.\nThe EMA's PRIME designation is designed to enhance support for the development of medicines that target unmet medical needs. To be eligible, treatment candidates must demonstrate the potential to offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options, based on early clinical data. The benefits of PRIME designation include early and enhanced interaction with the EMA to optimize development plans and the potential for accelerated assessment. More information on PRIME designation can be found on the EMA website at ema.europe.eu. \n\"We are very pleased that the EMA has recognized the potential for brensocatib to offer an entirely new treatment approach for NCFBE, a severe and chronic disease with significant unmet needs,\" said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. \"We are building on the strength of the Phase 2 WILLOW study with the initiation of a pivotal Phase 3 program for brensocatib that we hope will bring forth this urgently needed solution.\"\nThe PRIME designation is based on positive results from the global, randomized, double-blind, placebo-controlled Phase 2 WILLOW study of brensocatib in adults with NCFBE. Insmed plans to initiate the registrational Phase 3 ASPEN trial of brensocatib in patients with NCFBE by the end of 2020. More information on this study is available at clinicaltrials.gov (NCT04594369). \nIn addition to PRIME designation, brensocatib has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.\nAbout WILLOW\nWILLOW was a randomized, double-blind, placebo-controlled, parallel-group, multi-center, multi-national, Phase 2 study to assess the efficacy, safety and tolerability, and pharmacokinetics of brensocatib administered once daily ...