Therapy Areas: Hereditary Disorders
Insmed receives European Medicines Agency Priority Medicines designation for Brensocatib
16 November 2020 -

Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company, has received the Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its brensocatib intended for the treatment of non-cystic fibrosis bronchiectasis (NCFBE), it was reported on Friday.

Brensocatib is a novel, first-in-class, oral, reversible inhibitor of dipeptidyl peptidase 1 being produced by Insmed for the treatment of NCFBE a severe, chronic pulmonary disorder in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage, and other inflammatory diseases.

The PRIME designation is aimed at supporting development of medicines that target unmet medical requirements. To be eligible, treatment candidates must showcase the potential to provide a major therapeutic advantage over present treatments, or benefit patients without treatment options, based on early clinical data. The product has received PRIME designation based on positive results from the global, randomised, double-blind, placebo-controlled Phase 2 WILLOW study of brensocatib in adults with NCFBE.

Reportedly, Insmed plans to start the registrational phase three ASPEN trial of the product in patients with NCFBE by the end of 2020.



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