FDA Approves Insmed's Esmya for Uterine Fibroids.

Insmed Incorporated held a special call to discuss the FDA's decision regarding their application for the treatment of a specific disease. The company's presentation focused on the key points of the FDA's decision and its implications for the future of the treatment. The call provided insight into the company's strategy and plans moving forward.

The U.S. Food and Drug Administration (FDA) has approved Insmed Incorporated’s Brinsupri (brensocatib 10 mg and 25 mg tablets) as the first and only treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. This oral, once-daily treatment targets neutrophilic inflammation, a key driver of chronic airway inflammation in NCFB [1].

Brinsupri is expected to significantly impact the lives of the approximately 500,000 people in the U.S. diagnosed with NCFB, a chronic lung condition characterized by permanently widened and damaged airways. This condition leads to persistent mucus production, recurrent infections, and difficulty breathing [2].

The approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies. In ASPEN, patients taking Brinsupri 10 mg or 25 mg had a 21.1% and 19.4% reduction in the annual rate of exacerbations, respectively, compared to placebo. Both dosage strengths of Brinsupri also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period [1].

The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions in WILLOW. The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension [2].

Insmed plans to file applications for brensocatib with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) and anticipates commercial launches in 2026, pending approval in each territory [1].

The stock price of INSM increased by 6.20% to $119.89 at the last check on Tuesday, reflecting investor optimism about the FDA approval [1].

References:
[1] https://www.benzinga.com/news/fda/25/08/47070285/fda-approves-insmeds-drug-as-first-treatment-for-type-of-chronic-lung-disease
[2] https://investor.insmed.com/2025-08-12-FDA-Approves-BRINSUPRI-TM-brensocatib-as-the-First-and-Only-Treatment-for-Non-Cystic-Fibrosis-Bronchiectasis,-a-Serious,-Chronic-Lung-Disease