What's next in pulmonology — October 19, 2026

This edition covers three pending regulatory decisions in the United States between January and late April 2027: amikacin liposome inhalation suspension in non-refractory MAC lung disease, tozorakimab in COPD, and nebulized treprostinil in idiopathic pulmonary fibrosis. Dates come from official company releases; two of them are manufacturer estimates and are labeled as such.

1. Amikacin liposome inhalation suspension (ARIKAYCE) for MAC lung disease from diagnosis

[Pending regulatory decision] [United States] [Confirmed date: January 28, 2027 (PDUFA target date)]
What it is: Insmed sNDA for full approval in Mycobacterium avium complex lung disease; the FDA granted priority review (announced September 21, 2026). It is based on ENCORE (phase 3b, randomized, double-blind, placebo-controlled; n = 425 adults with new or recurrent, previously untreated infection; ARIKAYCE or placebo plus azithromycin and ethambutol for 12 months; primary endpoint: change in respiratory symptom score at month 13; secondary: culture conversion). The company reports the primary and secondary endpoints were met.
What problem it solves: In the US the label is currently limited to refractory MAC (no culture conversion after ≥6 months of multidrug therapy), under accelerated approval; most patients receive the oral regimen alone, with frequent relapses.
Critical take: Insmed-sponsored trial; the release gives no effect sizes (no symptom scores or conversion rates), and cost and tolerability (dysphonia, cough, bronchospasm) will shape use in our setting.
Source:
https://www.prnewswire.com/news-releases/fda-grants-priority-review-to-insmeds-snda-for-arikayce-amikacin-liposome-inhalation-suspension-for-treatment-of-mac-lung-disease-with-pdufa-target-action-date-set-for-january-28-2027-302884017.html
https://www.hcplive.com/view/fda-grants-priority-review-insmed-arikayce-snda-mac-lung-disease

2. Tozorakimab (anti-IL-33) in COPD with exacerbations

[Pending regulatory decision] [United States, European Union, China] [Estimated date: first quarter of 2027, per AstraZeneca]
What it is: BLA accepted by the FDA under priority review as add-on maintenance treatment for adults with COPD (announced September 8, 2026); also under review in the EU and China. In OBERON and TITANIA (n = 2,306 randomized; 300 mg every four weeks versus placebo) it reduced moderate/severe exacerbations by 29% and 34% in former smokers (primary endpoint) and by 30% and 29% in the overall population; in the pooled analysis, by 23% with eosinophils <150/µL, 34% with ≥150/µL and 43% with ≥300/µL. Published in NEJM.
What problem it solves: Available COPD biologics (dupilumab, mepolizumab) require an eosinophilic phenotype; many patients who keep exacerbating on triple inhaled therapy have no biologic option.
Critical take: Moderate relative reductions, smaller with low eosinophils; manufacturer-funded trials and a release without confidence intervals. A third phase 3 trial, MIRANDA (n = 1,454), also met its primary endpoint according to AstraZeneca, but its release gave no figures. Price will likely limit access in our region.
Source:
https://www.astrazeneca.com/media-centre/press-releases/2026/tozorakimab-demonstrated-statistically-significant-highly-clinically-meaningful-reduction-copd-exacerbations-oberon-titania-phase-iii-trials.html
https://www.astrazeneca.com/media-centre/press-releases/2026/tozorakimab-met-primary-endpoint-in-oberon-titania-phase-iii-trials-in-patients-with-copd.html
https://www.astrazeneca.com/media-centre/press-releases/2026/third-tozorakimab-positive-phase-iii-in-copd.html

3. Nebulized treprostinil (Tyvaso) in idiopathic pulmonary fibrosis

[Pending regulatory decision] [United States] [Estimated date: late April 2027, per United Therapeutics]
What it is: sNDA accepted by the FDA (acceptance announced by United Therapeutics on September 2, 2026), based on TETON-1 and TETON-2 (phase 3, randomized, double-blind, placebo-controlled, 52 weeks; primary endpoint: absolute change in FVC). In TETON-2 (n = 597, 75% on background antifibrotics) the difference versus placebo was 95.6 mL (95% CI 52.2–139.0); in the combined analysis of both trials, 111.8 mL (95% CI 79.7–144.0).
What problem it solves: Nintedanib, pirfenidone and nerandomilast slow but do not stop loss of lung function; adding a drug with a different mechanism on top of background therapy is the unmet need.
Critical take: FVC is a surrogate endpoint, there are no survival data, and nebulizing several times a day is a real burden for patients.
Source:
https://ir.unither.com/~/media/Files/U/United-Therapeutics-IR/documents/press-releases/2026/tyvaso-ipf-snda-acceptance-press-release.pdf
https://www.businesswire.com/news/home/20260311495225/en/United-Therapeutics-Corporation-Announces-Full-Results-of-TETON-2-Phase

*What's next in pulmonology — October 19, 2026*

1. FDA decides on Jan 28, 2027 on inhaled liposomal amikacin for MAC lung disease from diagnosis (ENCORE trial).
2. Tozorakimab (anti-IL-33) in COPD: FDA decision expected Q1 2027, per AstraZeneca; also under review in the EU and China.
3. Nebulized treprostinil in IPF: FDA review expected to finish in late April 2027, per United Therapeutics (TETON).

With a critical take on each item and official sources.
Full text and audio: https://boletinesmedicos.com/en/pulmonology/2026-10-19-viene.html
MedBulletins · boletinesmedicos.com

What's next in pulmonology (January – April 2027), with dates taken from official releases:

• January 28, 2027: FDA decision on inhaled liposomal amikacin in non-refractory MAC lung disease.
• Q1 2027 (AstraZeneca estimate): expected decision on tozorakimab, an anti-IL-33, in COPD, with effect also at low eosinophil counts.
• Late April 2027 (United Therapeutics estimate): review of nebulized treprostinil in idiopathic pulmonary fibrosis.

Each item covers the problem it solves, current practice and a critical take (sponsorship, surrogate endpoints, access in our setting).

Full text and audio: https://boletinesmedicos.com/en/pulmonology/2026-10-19-viene.html

#Pulmonology #COPD #PulmonaryFibrosis #NTM #MedicalNews

What's next in pulmonology: FDA decisions on inhaled amikacin for MAC (Jan 28), tozorakimab in COPD (Q1 2027) and treprostinil in IPF (late Apr 2027). Critical take: https://boletinesmedicos.com/en/pulmonology/2026-10-19-viene.html