The HCPFive: Top News for Healthcare Providers from the Week of 02/02

Welcome to The HCPFive, your go-to roundup for the latest in 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 clearance for a trial of gene-edited pig kidneys, a first-of-its-kind antibiotic approval, new guidelines for migraine, and more!

In just a few minutes, 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 February 02, 2025—let’s jump in!

Interested in oncology news? Check out The OncFive, from our sister publication OncLive.

Top News for Healthcare Providers from the Week of 02/02

1. FDA Clears First Xenotransplant Trial for Gene-Edited Kidneys

The FDA has cleared United Therapeutics to begin a first-in-human clinical trial evaluating the UKidney™, a 10-gene-edited pig kidney, in patients with end-stage renal disease. Led by United Therapeutics, the study will enroll up to 50 participants, focusing on those ineligible for traditional transplants or at high risk of prolonged wait times. This trial follows prior xenotransplant efforts, including a pair of genetically-edited pig kidney transplant at Massachusetts General Hospital in 2024 and 2025, respectively.

2. FDA Approves Combination Antibiotic Therapy for Complicated Intra-Abdominal Infections

The FDA has approved the first aztreonam/avibactam (Emblaveo) combination therapy for treating complicated intra-abdominal infections (cIAI) in adults with limited or no alternative options. Supported by the Phase 3 REVISIT trial, aztreonam/avibactam demonstrated efficacy against multidrug-resistant Gram-negative bacteria, including Metallo-β-lactamase (MBL)-producing pathogens. According to Abbvie, the therapy will be commercially available in the US by Q3 2025.

3. New ACP Migraine Guidelines Show No Advantage for More Costly, Newer Medications

On February 5, 2025, the American College of Physicians (ACP) released new guidelines for preventing episodic migraines, recommending cost-effective monotherapy options such as beta-blockers (metoprolol, propranolol), valproate, venlafaxine, or amitriptyline in nonpregnant adults. If ineffective, CGRP antagonists (atogepant, rimegepant) or CGRP monoclonal antibodies (eptinezumab, erenumab, fremanezumab, galcanezumab) may be considered. The ACP emphasized that newer, high-cost therapies offered no clinical advantage over traditional treatments based on a systematic review assessing both clinical effectiveness and economic impact.

4. Delgocitinib Effective for Chronic Hand Eczema in Teens in Pivotal Phase 3 Findings

On February 4, 2025, LEO Pharma announced positive phase 3 results for delgocitinib (Anzupgo) 20 mg/g cream in adolescents aged 12 to 17 years with moderate-to-severe chronic hand eczema. The DELTA TEEN trial met all primary and key secondary endpoints at 16 weeks, demonstrating efficacy and safety for patients unresponsive to topical corticosteroids. Led by Charité Universitätsmedizin Berlin investigators, this marks the fifth successful Phase 3 trial for delgocitinib, which is already approved for adults in several countries. Full results will be presented at upcoming scientific conferences.

5. Brensocatib, Potential First Treatment for Non-CF Bronchiectasis, Gets Priority Review

The FDA has accepted Insmed’s New Drug Application (NDA) for brensocatib, a potential first-in-class treatment for non-cystic fibrosis bronchiectasis, granting it Priority Review with a PDUFA date of August 12, 2025. Based on the Phase 3 ASPEN study, which demonstrated a significant reduction in pulmonary exacerbations over 52 weeks, brensocatib could become the first approved therapy for bronchiectasis. According to Insmed, regulatory submissions in the EU, UK, and Japan are planned for 2025, with potential launches in 2026.