一次情報の記録
FDAがbrensocatibのNDAを承認し、BRINSUPRIを非嚢胞性線維症気管支拡張症向け初の承認治療薬とした。同製品はその後米国で発売され、2025年第3四半期に2,810万ドルの収益を計上した。EUではCHMPの肯定的意見も採択され、英国および日本でも申請が受理された。
EX-99.1 2 ef20057768_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Insmed Reports Third-Quarter 2025 Financial Results and Provides Business Update — BRINSUPRI ™ (brensocatib ) Approved by FDA as First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis; Positive CHMP Opinion Adopted in the European Union and Application Accepted in Japan— — BRINSUPRI Total Revenue of $28.1 Million for the Third Quarter of 2025— —ARIKAYCE ® (amikacin liposome inhalation suspension) Total Revenue of $114.3 Million for the Third Quarter of 2025, Reflecting 22% Growth Over the Third Quarter of 2024— —Company Raises 2025 Global ARIKAYCE Revenue Guidance Range to $420 Million to $430 Million, Reflecting Double-Digit Growth Compared to 2024— —Topline Data Readout Anticipated for Phase 2b BiRCh Study of Brens