Insmed Announces that FDA Does Not Currently Plan to Hold Advisory Committee Meeting to Discuss New Drug Application for Brensocatib in Patients with Bronchiectasis
Insmed (INSM) announced that the FDA does not currently plan to hold an advisory committee meeting to discuss the New Drug Application (NDA) for brensocatib in patients with non-cystic fibrosis bronchiectasis. The FDA has maintained the application under Priority Review with a PDUFA target action date of August 12, 2025.
The NDA is supported by data from the ASPEN study, the largest Phase 3 study ever conducted in bronchiectasis patients. If approved, brensocatib would become the first approved treatment for bronchiectasis and the first in a new class of medicines called dipeptidyl peptidase 1 (DPP1) inhibitors for treating neutrophil-mediated diseases.
Insmed (INSM) ha annunciato che la FDA attualmente non prevede di tenere una riunione del comitato consultivo per discutere la Domanda di Nuovo Farmaco (NDA) per brensocatib nei pazienti con bronchiectasia non fibrotica cistica. La FDA ha mantenuto l'applicazione sotto Revisione Prioritaria con una data obiettivo di azione PDUFA del 12 agosto 2025.
La NDA è supportata dai dati dello studio ASPEN, il più grande studio di Fase 3 mai condotto su pazienti con bronchiectasia. Se approvato, brensocatib diventerebbe il primo trattamento approvato per la bronchiectasia e il primo in una nuova classe di farmaci chiamati inibitori della dipeptidil peptidasi 1 (DPP1) per il trattamento delle malattie mediate dai neutrofili.
Insmed (INSM) anunció que la FDA actualmente no planea llevar a cabo una reunión del comité asesor para discutir la Solicitud de Nuevo Medicamento (NDA) para brensocatib en pacientes con bronquiectasia no relacionada con fibrosis quística. La FDA ha mantenido la solicitud bajo Revisión Prioritaria con una fecha objetivo de acción PDUFA del 12 de agosto de 2025.
La NDA está respaldada por datos del estudio ASPEN, el estudio de Fase 3 más grande jamás realizado en pacientes con bronquiectasia. Si se aprueba, brensocatib se convertiría en el primer tratamiento aprobado para la bronquiectasia y el primero en una nueva clase de medicamentos llamados inhibidores de la dipeptidil peptidasa 1 (DPP1) para el tratamiento de enfermedades mediadas por neutrófilos.
Insmed (INSM)는 FDA가 비낭포성 섬유증 기관지 확장증 환자를 위한 brensocatib의 신약 신청(NDA)에 대해 자문 위원회 회의를 개최할 계획이 없다고 발표했습니다. FDA는 이 신청을 우선 심사 대상으로 유지하고 있으며, 2025년 8월 12일의 PDUFA 목표 행동 날짜를 설정했습니다.
NDA는 기관지 확장증 환자를 대상으로 한 가장 큰 3상 연구인 ASPEN 연구의 데이터를 기반으로 하고 있습니다. 승인될 경우, brensocatib은 기관지 확장증에 대한 첫 번째 승인 치료제가 되며, 중성구 매개 질환 치료를 위한 새로운 약물 클래스인 디펩타이드 펩타이드 1(DPP1) 억제제의 첫 번째가 될 것입니다.
Insmed (INSM) a annoncé que la FDA ne prévoit actuellement pas de tenir une réunion du comité consultatif pour discuter de la Demande de Nouveau Médicament (NDA) pour brensocatib chez les patients atteints de bronchiectasie non fibrose kystique. La FDA a maintenu la demande sous Revue Prioritaire avec une date cible d'action PDUFA du 12 août 2025.
La NDA est soutenue par des données de l'étude ASPEN, la plus grande étude de phase 3 jamais réalisée chez des patients atteints de bronchiectasie. Si elle est approuvée, brensocatib deviendrait le premier traitement approuvé pour la bronchiectasie et le premier d'une nouvelle classe de médicaments appelés inhibiteurs de la dipeptidyl peptidase 1 (DPP1) pour traiter les maladies médiées par les neutrophiles.
Insmed (INSM) gab bekannt, dass die FDA derzeit nicht plant, eine Sitzung des Beratungsausschusses abzuhalten, um den Antrag auf Zulassung eines neuen Arzneimittels (NDA) für brensocatib bei Patienten mit nicht-zystischer Fibrose-Bronchiektasie zu erörtern. Die FDA hat den Antrag unter Prioritätsprüfung gehalten, mit einem PDUFA-Zieldatum für Maßnahmen am 12. August 2025.
Das NDA wird durch Daten aus der ASPEN-Studie unterstützt, der größten Phase-3-Studie, die jemals bei Patienten mit Bronchiektasie durchgeführt wurde. Wenn genehmigt, würde brensocatib die erste genehmigte Behandlung für Bronchiektasie und die erste in einer neuen Klasse von Medikamenten, den Dipeptidylpeptidase-1 (DPP1)-Hemmern zur Behandlung neutrophilvermittelter Krankheiten, werden.
- FDA granted Priority Review status for brensocatib NDA
- No advisory committee meeting requirement, potentially streamlining approval process
- Potential to be first-ever approved treatment for bronchiectasis
- First-in-class DPP1 inhibitor medicine
- None.
Insights
The FDA's decision to forgo an advisory committee meeting for brensocatib marks a particularly encouraging development in the drug's regulatory journey. Historically, the FDA typically reserves advisory committees for cases where additional expert input is needed due to novel mechanisms of action, safety concerns, or complex efficacy data. The absence of an AdComm, especially for a first-in-class therapy like brensocatib, suggests the FDA is comfortable with the drug's safety and efficacy profile based on the ASPEN trial data.
The regulatory momentum is further reinforced by the Priority Review status, which is granted to drugs that would provide significant improvements in the treatment of serious conditions. For context, drugs reviewed under Priority Review have historically shown higher approval rates, approximately
The market opportunity for brensocatib is substantial. Non-cystic fibrosis bronchiectasis represents an orphan indication with no approved treatments, affecting approximately 340,000-520,000 patients in the U.S. As a first-in-class DPP1 inhibitor, brensocatib could establish Insmed as the leader in neutrophil-mediated diseases, potentially opening doors to additional indications.
However, several key considerations warrant attention:
- The FDA's review will likely focus intensively on the ASPEN study's safety data, given the novel mechanism of action
- Pricing and market access strategies will be important for commercial success in this orphan indication
- The company's commercial infrastructure readiness for a potential launch by late 2025 will be critical
—FDA Reaffirms Application is Under Priority Review with a PDUFA Target Action Date of August 12, 2025—
"We are very pleased with our ongoing communications with the FDA about the NDA for brensocatib," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "We are committed to working closely with the agency to successfully complete the review and potentially bring forward this much-needed treatment for patients with bronchiectasis."
The FDA had previously granted Priority Review to Insmed's NDA for brensocatib and set a target action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA). This NDA is based on data from the landmark
About Bronchiectasis
Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. Today, approximately 500,000 patients in the
About Brensocatib
Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis, chronic rhinosinusitis without nasal polyps, hidradenitis suppurativa, and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any indication in any jurisdiction.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including a therapy approved in
Headquartered in
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Contact:
Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
bryan.dunn@insmed.com
Michael V. Morabito, Ph.D.
Director, Investor Relations
(917) 936-8430
michael.morabito@insmed.com
Gianna De Palma
Manager, Investor Relations
(973) 886-2236
gianna.depalma@insmed.com
Media:
Mandy Fahey
Vice President, Corporate Communications
(732) 718-3621
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated
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