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.
Chemomab secures new patents for CM-101 monoclonal antibody
argenx receives FDA priority review for VYVGART Hytrulo in CIDP
AffaMed Therapeutics' DEXTENZA NDA accepted by Singapore regulator
AbbVie showcases gastroenterology portfolio at ECCO Congress
Japan approves Sanofi's Dupixent for chronic spontaneous urticaria
Ono partners with Shattuck Labs for bifunctional fusion proteins
Zymedi commences first in human dosage of ZMA001
Bio-Thera Solutions commences dosing in BAT6026 Phase IA/IIB clinical trial
EicOsis Human Health commences EC5026 Phase 1b multiple-ascending dose clinical trial
Takeda's HyQvia approved for maintenance therapy in CIDP patients
Celltrion USA submits CT-P47 Biologics License Application to FDA
Formosa Pharmaceuticals agrees licensing deal in Brazil for APP13007