Brinsupri (Brensocatib)
PRIMEAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- Brensocatib
- Company
- Insmed Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Bronchiectasis; Lung Diseases
- CHMP opinion
- Thu 16 Oct 2025
- EU approval
- Tue 18 Nov 2025
- Designations
- PRIME, Additional monitoring
- Application
- EMEA/H/C/005820
- ATC
- R03
- Official record
- www.ema.europa.eu
Indication
Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
Regulatory milestones
Tue 18 Nov 2025🇪🇺 EU approval (EC decision)
Brinsupri (Brensocatib) approved in the EU
Marketing authorisation to Insmed Netherlands B.V.; PRIME, Additional monitoring · source
Thu 16 Oct 2025🇪🇺 CHMP positive opinion
Brinsupri (Brensocatib): CHMP positive opinion
Insmed Netherlands B.V.; PRIME, Additional monitoring · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.