Respiratory Today—December 19, 2025

This week’s respiratory update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.

In Today’s Newsletter

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🫁 Merck receives positive EU CHMP opinion for expanded use of WINREVAIR™ (sotatercept) in adults with PAH [1] [EU • 12 Dec 2025]

https://www.merck.com/news/merck-receives-positive-eu-chmp-opinion-for-expanded-use-of-winrevair-sotatercept-in-adults-with-pulmonary-arterial-hypertension-pah-who-group-1-pulmonary-hypertension/

Context: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends approval for expanded use of WINREVAIR to treat adults with PAH in WHO FC II, III, and IV.

Key point: The expanded indication aims to include a broader patient population, offering a significant 76% reduction in morbidity and mortality risk in Phase 3 trials.

Implication: This could provide a transformative option for patients with advanced PAH, improving survival and quality of life.

🌬️ GSK’s Depemokimab receives positive CHMP opinion for severe asthma and CRSwNP [2] [EU • 12 Dec 2025]

https://www.gsk.com/en-gb/media/press-releases/depemokimab-receives-positive-chmp-opinion-for-severe-asthma-with-type-2-inflammation/

Context: Depemokimab receives a positive CHMP opinion for two indications: severe asthma with type 2 inflammation and CRSwNP.

Key point: The approval is based on Phase 3 trial data, showing reduced exacerbations and improved control with a twice-yearly dosing regimen.

Implication: Depemokimab could become a first-line treatment for severe asthma and CRSwNP, addressing a major unmet need in respiratory medicine.

💨 GSK’s Nucala (mepolizumab) receives positive CHMP opinion for COPD [3] [EU • 12 Dec 2025]

https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-receives-positive-chmp-opinion-for-treatment-of-chronic-obstructive-pulmonary-disease/

Context: Nucala has received a positive CHMP opinion for the treatment of COPD with eosinophilic phenotype.

Key point: This approval could offer a new biologic option for COPD patients, particularly those with elevated eosinophil levels.

Implication: Nucala could reduce exacerbations and hospitalizations, improving the overall management of COPD in Europe.

🧬 4DMT announces positive interim clinical data from 4D-710 AEROW Phase 1 trial in CF lung disease [4] [US • 17 Dec 2025]

https://www.globenewswire.com/news-release/2025/12/17/3206872/0/en/4DMT-Announces-Positive-Interim-Clinical-Data-from-4D-710-AEROW-Phase-1-Clinical-Trial-in-Cystic-Fibrosis-Lung-Disease.html

Context: 4DMT reports promising interim data from its Phase 1 trial for 4D-710, a potential genetic therapy for cystic fibrosis.

Key point: 4D-710 demonstrated clinically meaningful improvements in lung function, with durable CFTR expression observed.

Implication: This could provide a new, redosable, variant-agnostic option for CF patients, significantly improving long-term outcomes.

🇬🇧 GSK’s Exdensur (depemokimab) approved in the UK for severe asthma and CRSwNP [5] [UK • 17 Dec 2025]

https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-the-uk-for-treatment-of-asthma-with-type-2-inflammation-and-chronic-rhinosinusitis-with-nasal-polyps/

Context: Exdensur (depemokimab) is now approved in the UK as an add-on maintenance treatment for severe asthma and CRSwNP.

Key point: Exdensur’s ultra-long-acting formulation allows for just two doses per year.

Implication: This approval may shift the treatment landscape for severe asthma and CRSwNP, reducing hospitalizations and exacerbations.

🇺🇸 GSK’s Exdensur (depemokimab) approved by US FDA for severe asthma [6] [US • 17 Dec 2025]

https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/

Context: Exdensur (depemokimab) has received FDA approval for severe asthma with type 2 inflammation.

Key point: The approval is based on Phase 3 trial results showing a 58% reduction in asthma exacerbations with just two doses per year.

Implication: This could dramatically improve patient outcomes by offering a convenient, long-acting biologic option.

🫁 Sanofi’s efdoralprin alfa earns orphan designation in the EU for AATD-related emphysema [7] [EU • 17 Dec 2025]

https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-17-06-00-00-3206714

Context: Sanofi’s efdoralprin alfa receives orphan designation for treating AATD-related emphysema.

Key point: The treatment showed superior results compared to plasma-derived therapies in Phase 2 trials.

Implication: Efdoralprin alfa may become a leading therapy for this rare disease, with the potential to improve lung function and quality of life.

🔬 Insmed provides clinical and business update, discontinues brensocatib program for CRSsNP [8] [US • 17 Dec 2025]

https://investor.insmed.com/2025-12-17-Insmed-Provides-Clinical-and-Business-Update

Context: Insmed discontinues the brensocatib program for CRSsNP after Phase 2b trial failure.

Key point: While the trial did not meet efficacy endpoints, brensocatib showed no new safety concerns.

Implication: Insmed is refocusing on other therapeutic areas and has acquired a new monoclonal antibody, INS1148, for respiratory diseases.

Why it matters

PAH Treatment: WINREVAIR’s expanded approval in Europe offers a promising treatment for PAH patients in advanced stages [1].
Severe Asthma & CRSwNP: Depemokimab’s positive opinions in the EU and US could revolutionize asthma and CRSwNP management with less frequent dosing [2][5][6].
COPD Management: Nucala’s CHMP approval for COPD provides a new option for patients with eosinophilic inflammation [3].
CF Therapy: 4D-710’s interim data brings hope for durable and redosable CF treatment [4].
Rare Diseases: Efdoralprin alfa’s orphan designation supports its potential as a breakthrough therapy for AATD-related emphysema [7].
Brensocatib’s Discontinuation: Despite disappointing results, the acquisition of INS1148 represents a shift in Insmed’s strategy towards new respiratory therapies [8].

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FAQ

What is WINREVAIR’s expanded use in PAH?

WINREVAIR has received a positive CHMP opinion to treat a broader range of PAH patients, including those in WHO FC IV, based on its ability to reduce morbidity and mortality [1].

How effective is Depemokimab in treating severe asthma?

Depemokimab has been shown to significantly reduce asthma exacerbations with just two doses per year, offering a new treatment approach for severe asthma and CRSwNP [2][5].

What is 4DMT’s 4D-710 for CF?

4D-710 is a genetic therapy showing promising early results in improving lung function and offering a durable solution for cystic fibrosis patients [4].

What is efdoralprin alfa’s significance?

Efdoralprin alfa is a potential breakthrough therapy for AATD-related emphysema, with clinical trial results showing superior efficacy over standard treatments [7].

Entities / Keywords

Merck; WINREVAIR; pulmonary arterial hypertension; GSK; Depemokimab; Nucala; severe asthma; chronic rhinosinusitis with nasal polyps; 4DMT; 4D-710; cystic fibrosis; Sanofi; efdoralprin alfa; AATD; Insmed; brensocatib; INS1148; orphan designation.