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Find Clinical Drug Pipeline Developments & Deals by Insmed
INS1007 (brensocatib) is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases.
ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function.
Under the terms of the agreement, taiba will be responsible for the named patient supply program with intent to commercialize ARIKAYCE in the region following receipt of marketing authorization(s) in the territory.
The approval by the MHLW is based on results from the Phase 3 CONVERT study, which demonstrated that once-daily ARIKAYCE, with MDR, improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared to MDR therapy alone.
INS1009 (treprostinil palmitil) inhalation powder is a dry powder formulation of treprostinil palmitil, which being evaluated for the treatment of patients with PAH.
Treprostinil palmitil inhalation powder is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain.
First patient was dosed in late December, 2020, in the frontline clinical trial program of ARIKAYCE® (amikacin liposome inhalation suspension) in patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).
The CHMP opinion is based on results from the Ph 3 CONVERT study, which showed that once-daily ARIKAYCE, when combined with multi-drug regimen, improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared to MDR therapy alone.
The evidence-based guidelines recommend the use of ARIKAYCE for the treatment of refractory NTM lung disease caused by Mycobacterium avium complex as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options.
FDA has granted breakthrough therapy designation to brensocatib for treating patients with NCFBE, recognizing the strength of data from Company's Phase 2 WILLOW study and the potential for brensocatib to offer a novel, first-in-class treatment approach to bronchiectasis.