Watch Our Video Summary Capturing Top Respiratory News from the Last Two Weeks
From AIRSUPRA’s BATURA label expansion and Tyvaso’s pivotal TETON-2 results to Tezspire’s EU progress—this episode’s signals are robust. We span asthma, pulmonary fibrosis, respiratory infection, and immunology, with regulatory milestones and clinical breakthroughs across areas, underscoring competitive momentum and shifting treatment paradigms.
Top Stories Covered in This Video
💨 AIRSUPRA® (albuterol/budesonide) US label adds BATURA mild-asthma efficacy [1] [US • 18 Sep 2025]
Context: Builds on MANDALA (moderate–severe) and DENALI (lung function). BATURA was decentralized; n=2,421; adults ≥18 benefit cited in PI.
Key point: FDA approved sNDA; US PI now includes Phase IIIb BATURA showing 46% lower severe exacerbation risk vs as-needed albuterol (HR 0.54; p<0.001) in mild asthma.
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 United Therapeutics to review TETON-2 Tyvaso® in IPF (pivotal met primary) [2] [US • 19 Sep 2025]
https://ir.unither.com/press-releases/2025/09-19-2025-120024056
Context: Phase 3, n=597, 52 weeks, nebulized treprostinil QID, stratified by background therapy; global multicenter.
Key point: Company announced a Sept 28 webcast to review ERS-presented TETON-2 data; study met primary endpoint (absolute FVC improvement vs placebo) with most secondary endpoints favoring treatment.
Implication: May influence prescriber choice and payer reviews pending full data.
👃 Tezspire (tezepelumab) CHMP positive for CRSwNP [3] [EU • 22 Sep 2025]
Context: Double-blind Phase 3 in adults with severe CRSwNP; safety consistent with known profile; regulatory reviews also underway in US/China/Japan.
Key point: WAYPOINT hit co-primaries: NPS −2.08 and NCS −1.04 at week 52 vs placebo; near-elimination of surgery (98%) and reduced systemic corticosteroid use (89%).
Implication: May influence prescriber choice and payer reviews pending full data.
🍼 ENFLONSIA™ (clesrovimab) wins EU CHMP positive opinion for infant RSV prevention [4] [EU • 19 Sep 2025]
Context: Supported by Phase 2b/3 CLEVER and Phase 3 SMART (vs palivizumab); already approved in US & UAE; EC decision pending.
Key point: If approved, would be first European infant RSV option with single fixed dose regardless of weight; designed for protection through ~5 months.
Implication: May influence prescriber choice and payer reviews pending full data.
🦠 Vapendavir human rhinovirus COPD challenge shows clinical signal [5] [EU • 28 Sep 2025]
Context: Human challenge; treatment started after symptom onset; outpatient living conditions; Phase 2/3 multicenter trial planned for 2026.
Key point: In ERS late-breaker (n=40, Stage 2 COPD), vapendavir improved patient-reported outcomes, reduced viral load, and maintained lung function vs placebo; well tolerated.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Amneal files US BLA for Xolair® (omalizumab) biosimilar [6] [US • 26 Sep 2025]
Context: Amneal holds exclusive US commercialization rights; expects multiple biosimilar launches 2026–2027.
Key point: Earlier-than-expected BLA submission (Kashiv-developed); aims for first-wave entry into $4.1B US market.
Implication: Introduces competition that may affect pricing and formulary access.
📉 Zelasudil (RXC007; Redx) Phase 2a IPF “signal-searching” data at ERS [7] [EU • 29 Sep 2025]
Context: n=48; randomized 3:1; combinable with pirfenidone/nintedanib; no treatment-related SAEs; ALT/AST increases resolved with interruption.
Key point: Numerical reductions in FVC decline vs placebo at 12 weeks (−47% at 20 mg BID; −13% at 50 mg BID); stabilization continued in OLE; supportive circulating biomarkers.
Implication: May influence prescriber choice and payer reviews pending full data.
📈 Deupirfenidone (LYT-100; PureTech/Celea) OLE switch cohorts stabilize FVC [8] [EU • 29 Sep 2025]
Context: Phase 2b randomized part previously showed slower FVC decline vs placebo/pirfenidone; >90% enrolled into OLE.
Key point: In ELEVATE IPF OLE, placebo→LYT-100 +20 mL and pirfenidone→LYT-100 −23.1 mL over 26 weeks; tolerability remained favorable; regulatory engagement underway.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Infant RSV prevention may broaden with clesrovimab’s fixed-dose approach in Europe.
- IPF pipeline momentum spans mechanisms (ROCK2, deuterated pirfenidone), with early stabilization signals.
- Anti-inflammatory rescue in asthma advances, as AIRSUPRA’s PI now reflects mild-asthma exacerbation risk reduction.
- Biosimilar activity in respiratory-adjacent immunology (omalizumab) could shift access and spend.
📢 Stay Ahead in Respiratory research!
✅ Like, share, and subscribe to our YouTube channel for future highlights. Don’t miss our weekly newsletters with the latest updates in respiratory medicine.
✅ Contact LucidQuest at info@lqventures.com for expert guidance on innovations shaping the future of respiratory care and treatment.
FAQ
What changed for AIRSUPRA in the US label?
The FDA approved an sNDA adding Phase IIIb BATURA data to the PI, including a 46% reduction in severe exacerbation risk vs as-needed albuterol in mild asthma; safety aligned with prior profile [1].
Did Tyvaso® show efficacy in IPF in TETON-2?
United Therapeutics states TETON-2 met its primary endpoint (absolute FVC improvement vs placebo) and most secondaries; details were scheduled for ERS presentation and company webcast [2].
How strong is the Tezspire CRSwNP evidence?
WAYPOINT demonstrated significant reductions in Nasal Polyp Score (−2.08) and nasal congestion (−1.04) at 52 weeks vs placebo, with marked drops in surgery (98%) and systemic steroid use (89%) [3].
What is distinctive about clesrovimab’s dosing?
Per the CHMP opinion, ENFLONSIA is designed as a single fixed dose regardless of weight to protect infants through a typical 5-month RSV season; EU decision is pending [4].
Are there new IPF signals beyond current antifibrotics?
Yes. Zelasudil showed numerical FVC benefits with supportive biomarkers and SOC combinability [7], and deupirfenidone OLE switch cohorts showed FVC stabilization with favorable tolerability [8].
When might an omalizumab biosimilar enter the US market?
Amneal/Kashiv filed a BLA and aim for first-wave entry; timing depends on FDA review and potential litigation; the market is ~$4.1B annually in the US [6].
Entities / Keywords
AstraZeneca; AIRSUPRA; albuterol/budesonide; BATURA; MANDALA; DENALI; United Therapeutics; Tyvaso; treprostinil; TETON-2; IPF; AstraZeneca; Amgen; Tezspire; tezepelumab; CRSwNP; WAYPOINT; Merck (MSD); ENFLONSIA; clesrovimab; RSV; infants; CLEVER; SMART; Altesa BioSciences; vapendavir; COPD; human rhinovirus challenge; Amneal; Kashiv BioSciences; omalizumab; Xolair; biosimilar; Redx Pharma; zelasudil; RXC007; ROCK2; IPF; biomarkers; PureTech Health; Celea Therapeutics; deupirfenidone; LYT-100; ELEVATE IPF; OLE;
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://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/
- https://www.prnewswire.com/news-releases/altesa-biosciences-presents-findings-demonstrating-beneficial-effects-of-vapendavir-for-treating-rhinovirus-infections-in-copd-challenge-study-302568959.html
- https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-BLA-Submission-of-Biosimilar-Candidate-to-XOLAIR-omalizumab/default.aspx
- https://www.redxpharma.com/wp-content/uploads/2025/09/RXC007-ERS-data-announcement-29-September-2025.pdf
- https://news.puretechhealth.com/news-releases/news-release-details/puretech-presents-new-data-phase-2b-open-label-extension-study