Advertisement

The HCPFive: Top News for Healthcare Providers from the Week of 05/17

Published on: 

Stay updated with the latest healthcare breakthroughs, including FDA approvals and phase 3 data.

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know — whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include FDA approval of baxdrostat (Baxfendy) as the first-in-class aldosterone synthase inhibitor for adults with uncontrolled hypertension, phase 3 TETON-1 data showing inhaled treprostinil preserved lung function in idiopathic pulmonary fibrosis, a discussion with Klaus Rabe, MD, PhD, on the mixed AERIFY results for itepekimab and what they mean for the drug's COPD approval pathway, FDA accelerated approval of bulevirtide-gmod (Hepcludex) as the first treatment for chronic hepatitis delta virus infection, and topline phase 3 TRIUMPH-1 results showing retatrutide achieved up to 28.3% body weight reduction at 80 weeks in adults with obesity.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here's your quick dive into the top stories for the week of May 17, 2026 — let's jump in!

FDA Approves Baxdrostat for Uncontrolled Hypertension on Background Therapy

The FDA approved baxdrostat (Baxfendy; AstraZeneca) on May 18 as the first aldosterone synthase inhibitor for adults with hypertension not adequately controlled on 2 or more antihypertensive agents, introducing a first-in-class mechanism targeting aldosterone production upstream of mineralocorticoid receptor blockade. In the phase 3 BaxHTN trial, baxdrostat 2 mg produced a placebo-adjusted seated systolic blood pressure reduction of 9.8 mmHg at week 12 (P <.001), with consistent effects across uncontrolled and resistant hypertension subgroups; key safety considerations include hyperkalemia, reported in up to 10.2% of patients at the 2 mg dose, and hyponatremia.

TETON-1: Treprostinil Preserved Lung Function in Idiopathic Pulmonary Fibrosis

Phase 3 TETON-1 results presented at ATS 2026 and simultaneously published in the New England Journal of Medicine showed that nebulized treprostinil (Tyvaso) met its primary endpoint, demonstrating superiority over placebo in preserving absolute FVC by 130.1 mL over 52 weeks in patients with IPF, with pooled TETON-1 and TETON-2 analyses showing a 31% reduction in clinical worsening risk and a 48% reduction in acute IPF exacerbations. United Therapeutics plans to file a supplemental NDA with a priority review request by the end of summer 2026; the therapy remains investigational for IPF, though both the FDA and European Medicines Agency have granted it orphan designation for this indication.

Mixed AERIFY Data May Delay Itepekimab Approval Pathway in COPD, With Klaus Rabe, MD, PhD

Speaking with HCPLive at ATS 2026, Klaus Rabe, MD, PhD, addressed the discordant AERIFY results for itepekimab — an anti–IL-33 monoclonal antibody that reduced moderate or severe COPD exacerbations by 27.1% in AERIFY-1 but failed to replicate the finding in AERIFY-2 despite nearly identical trial designs — explaining that positive results from a single trial are unlikely to support regulatory submission, and that additional clinical evidence will be needed before a regulatory pathway becomes viable. Rabe also cautioned against overinterpreting divergent FEV₁ signals across the 2 trials, noting inconsistent dose-response patterns, and characterized itepekimab as unlikely to become clinically available in the near term.

Bulevirtide Receives Historic First FDA Approval for Chronic Hepatitis Delta

The FDA granted accelerated approval on May 22 to bulevirtide-gmod (Hepcludex; Gilead Sciences), the first approved therapy for chronic hepatitis delta virus (HDV) infection in the US, indicated for adults without cirrhosis or with compensated cirrhosis based on phase 3 MYR301 data demonstrating reductions in HDV RNA and ALT normalization through up to 144 weeks of treatment. The first-in-class entry inhibitor — which blocks HDV and HBV entry into liver cells — received Breakthrough Therapy, Orphan Drug, and Priority Review designations; the label carries a boxed warning for severe acute exacerbations of HDV and HBV upon discontinuation.

Retatrutide Meets Weight Loss Endpoints in Phase 3 Obesity Trial

Topline results from the phase 3 TRIUMPH-1 trial announced May 21 showed that all 3 doses of retatrutide — a first-in-class GIP/GLP-1/glucagon triple receptor agonist — met the primary and key secondary weight reduction endpoints at 80 weeks in 2,339 adults with obesity or overweight and at least 1 weight-related comorbidity, with the 12 mg dose achieving 28.3% mean body weight loss versus 3.9% on placebo and 62.5% of patients reaching ≥25% weight loss. Seven additional TRIUMPH program readouts are expected in 2026, including TRIUMPH-2 in obesity with type 2 diabetes and TRIUMPH-3 in obesity with established cardiovascular disease; retatrutide remains investigational and available only to clinical trial participants.


Advertisement
Advertisement