The HCPFive: Top News for Healthcare Providers from the Week of 1/26

Author(s):

Key Takeaways

Suzetrigine, a non-opioid pain signal inhibitor, offers a new class of pain medication, reducing opioid-related risks by targeting NaV1.8 sodium channels.
Semaglutide's approval for type 2 diabetes and CKD reduces kidney and cardiovascular risks, expanding its indications as a GLP-1 receptor agonist.
Meloxicam and rizatriptan combination therapy provides rapid migraine relief, overcoming previous manufacturing concerns without new clinical trials.
Roche's Lp(a) assay, cleared by the FDA, measures lipoprotein (a) in molar units, aiding cardiovascular risk assessment with upcoming Lp(a)-lowering treatments.
Efruxifermin shows potential in reversing cirrhosis in MASH patients, with significant results in the phase 2b SYMMETRY study, offering hope for future therapies.

Our top 5 headlines include approvals for a non-opioid pain reliever, the latest indication for semaglutide, positive phase 2 data in MASH, and more.

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. 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 January 26—let’s jump in!

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

1. FDA Approves Suzetrigine, a Non-Opioid Option, for Treatment of Acute Pain

On January 30, 2025, the FDA approved suzetrigine (Journavx), a non-opioid pain signal inhibitor, for the treatment of adults with moderate to severe acute pain. This approval marks the first new class of pain medication in over 20 years, offering an alternative to opioids and reducing associated risks. Suzetrigine works by selectively inhibiting NaV1.8, a sodium channel in pain-sensing neurons, providing pain relief without the addiction risks tied to opioids. In phase 2 and 3 trials, the drug showed significant efficacy in reducing acute pain following surgeries like abdominoplasty and bunionectomy.

2. FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease

On January 28, 2025, the FDA approved semaglutide (Ozempic) to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). This approval follows the phase 3b FLOW trial, which showed a 24% relative risk reduction in major kidney and cardiovascular outcomes with semaglutide compared to placebo. Semaglutide, originally approved in 2017 for diabetes and in 2020 for cardiovascular risk reduction, is now the most broadly indicated GLP-1 receptor agonist in its class.

3. FDA Approves Meloxicam and Rizatriptan (Symbravo) for Acute Migraine With or Without Aura

On January 30, 2025, the FDA approved meloxicam and rizatriptan (Symbravo) for the acute treatment of migraines with or without aura. The approval follows positive results from the MOMENTUM and INTERCEPT Phase 3 trials, which showed the combination therapy was superior to placebo in relieving migraine pain and symptoms. Patients treated with meloxicam and rizatriptan experienced significantly faster pain relief, with pain freedom achieved as early as 30 minutes. This approval follows a 2022 Complete Response Letter that addressed manufacturing concerns but did not require new clinical trials.

4. FDA Grants 510(k) Clearance to First Lp(a) Blood Test in Molar Units

On January 29, 2025, the FDA granted 510(k) clearance to Roche's Tina-quant® Lipoprotein (a) Gen.2 Molarity assay, the first test in the US to measure lipoprotein (a) [Lp(a)] in molar units. This assay will help evaluate lipid metabolism disorders and atherosclerotic cardiovascular disease (ASCVD) risk when combined with other tests. Lp(a) is a significant, yet under-recognized risk factor for ASCVD, with elevated levels linked to plaque buildup and clot formation. The test provides clinicians with a more accurate method for assessing cardiovascular risk, especially with upcoming Lp(a)-lowering treatments.

5. Efruxifermin Reverses MASH Compensated Cirrhosis in Phase 2b SYMMETRY Study

On January 27, 2025, Akero Therapeutics announced positive topline week 96 results from the phase 2b SYMMETRY study of efruxifermin in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). The study found that 39% of patients treated with 50 mg of efruxifermin experienced reversal of cirrhosis with no worsening of MASH, compared to 15% with placebo (P = .009). These results offer hope for a potential treatment for cirrhosis, as no approved therapies currently address this stage of MASH.