Respiratory Health Update: AIRSUPRA Label Expansion, TETON-2 IPF Win, Tezspire CHMP Nod and More
Stay current with pivotal respiratory updates! This week’s highlights include AIRSUPRA’s new FDA label for mild asthma, TETON-2’s IPF results, and Tezspire’s CHMP nod for nasal polyps. Cytisinicline improved quit rates in COPD, and ENFLONSIA received EU support for RSV prevention, reinforcing global progress in respiratory care.
In Today’s Newsletter
💨 AIRSUPRA® US label updated with BATURA severe exacerbation data [1] [US • 18 Sep 2025]
https://www.astrazeneca-us.com/media/press-releases/2025/AIRSUPRA-albuterol-budesonide-US-prescribing-information-updated-to-reflect-the-statistically-significant-severe-exacerbation-risk-reduction-in-patients-with-mild-asthma-compared-with-albuterol.html
Context: FDA-approved sNDA adds Phase IIIb BATURA to US PI; prior MANDALA/DENALI supported approval.
Key point: As-needed AIRSUPRA cut severe exacerbation risk by 46% vs albuterol in mild asthma (HR 0.54; 95% CI 0.40–0.72; p<0.001); safety consistent.
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 United Therapeutics to review successful TETON-2 (IPF) Tyvaso® data [2] [US • 19 Sep 2025]
https://ir.unither.com/press-releases/2025/09-19-2025-120024056
Context: Phase 3, 597-patient, double-blind, nebulized treprostinil in IPF over 52 weeks; ERS data review webcast announced.
Key point: TETON-2 met primary endpoint (absolute FVC improvement vs placebo); most secondary endpoints also favored active (per release).
Implication: May influence prescriber choice and payer reviews pending full data.
👃 Tezspire® wins EU CHMP positive opinion for CRSwNP [3] [EU • 22 Sep 2025]
https://www.astrazeneca.com/media-centre/press-releases/2025/tezspire-recommended-for-approval-in-eu-for-crswnp.html
Context: WAYPOINT Phase 3 in adults with CRSwNP; NEJM-published, AAAAI/WAO-presented dataset.
Key point: Significant reductions vs placebo in NPS (-2.08) and nasal congestion (-1.04); marked reductions in surgery and systemic steroid use.
Implication: Introduces competition that may affect pricing and formulary access.
🚭 Cytisinicline shows quit-rate benefit in COPD subgroup (Thorax) [4] [US • 22 Sep 2025]
https://achievelifesciences.com/achieve-announces-thorax-publication-of-cytisiniclines-potential-efficacy-and-tollerability-for-smoking-cessation-in-individuals-with-copd/
Context: Post hoc analysis of Phase 3 ORCA-2/ORCA-3 (n>1,600); subgroup with self-reported COPD.
Key point: Cytisinicline increased continuous abstinence vs placebo in COPD and non-COPD; favorable tolerability; no serious treatment-related AEs.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
👶 ENFLONSIA™ (clesrovimab) gets CHMP positive opinion for infant RSV prevention [5] [EU • 19 Sep 2025]
Context: Long-acting mAb; supported by CLEVER and SMART Phase 2b/3 trials; already approved in US/UAE.
Key point: Single fixed dose regardless of weight; designed for 5-month season coverage; CHMP recommends EU approval.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Label-enabled BATURA data positions AIRSUPRA as an anti-inflammatory rescue across asthma severities.
- Positive TETON-2 raises the bar for IPF interventions beyond antifibrotics.
- Tezspire’s CRSwNP nod broadens epithelial-cytokine targeting beyond severe asthma.
- Cytisinicline could fill a COPD-specific cessation gap if approved.
- Clesrovimab adds fixed-dose convenience to the infant RSV prevention toolkit in Europe.
📢 Stay Ahead in Respiratory Health Research!
✅ Contact LucidQuest at info@lqventures.com for strategic guidance on Respiratory Health innovations and clinical research
FAQ
What changed for AIRSUPRA in the US label?
BATURA Phase IIIb results were added, showing a 46% reduction in severe exacerbation risk vs albuterol in mild asthma; safety consistent with prior profile [1].
Did TETON-2 meet its endpoints for IPF?
Per United Therapeutics, the study improved absolute FVC vs placebo and most secondary endpoints favored treatment; full data are being reviewed at ERS [2].
What does CHMP’s opinion mean for Tezspire in CRSwNP?
It’s a step toward EU approval based on WAYPOINT, which showed significant NPS and congestion reductions and less need for surgery/systemic steroids [3].
How strong is the evidence for cytisinicline in COPD smokers?
A post hoc analysis of two randomized Phase 3 trials found higher continuous abstinence vs placebo with good tolerability in COPD and non-COPD groups [4].
What differentiates ENFLONSIA for infant RSV?
It’s a long-acting mAb with a single fixed dose regardless of weight, intended to cover a 5-month RSV season; CHMP issued a positive opinion for EU approval [5].
Entities / Keywords
AstraZeneca; AIRSUPRA® (albuterol/budesonide); BATURA; MANDALA; DENALI; mild asthma; severe exacerbation; United Therapeutics; Tyvaso® (treprostinil) Inhalation Solution; TETON-2; idiopathic pulmonary fibrosis (IPF); AstraZeneca/Amgen; Tezspire® (tezepelumab); CRSwNP; WAYPOINT; Achieve Life Sciences; Cytisinicline; ORCA-2; ORCA-3; smoking cessation; COPD; Merck (MSD); ENFLONSIA™ (clesrovimab); RSV prevention; CLEVER; SMART.
References
- https://www.astrazeneca-us.com/media/press-releases/2025/AIRSUPRA-albuterol-budesonide-US-prescribing-information-updated-to-reflect-the-statistically-significant-severe-exacerbation-risk-reduction-in-patients-with-mild-asthma-compared-with-albuterol.html
- https://ir.unither.com/press-releases/2025/09-19-2025-120024056
- https://www.astrazeneca.com/media-centre/press-releases/2025/tezspire-recommended-for-approval-in-eu-for-crswnp.html
- https://achievelifesciences.com/achieve-announces-thorax-publication-of-cytisiniclines-potential-efficacy-and-tollerability-for-smoking-cessation-in-individuals-with-copd/
- https://www.merck.com/news/merck-receives-positive-eu-chmp-opinion-for-enflonsia-clesrovimab-for-the-prevention-of-respiratory-syncytial-virus-rsv-in-infants-during-their-first-rsv-season/