The HCPFive: Top News for Healthcare Providers from the Week of 12/14

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 the US Food and Drug Administration approvals of lerodalcibep-liga (Lerochol) injection for adults with hypercholesterolemia, depemokimab-ulaa (Exdensur) as an add-on maintenance treatment for severe asthma, and fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, as well as Breakthrough Device Designation granted to to the Holly™ implantable, continuous dialysis system and positive topline results from a pair of phase 3 studies of zasocitinib in adults with moderate-to-severe plaque psoriasis (PsO).

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 December 14, 2025—let’s jump in!

FDA Approves Lerodalcibep-liga (Lerochol) for LDL-C Reduction in Hypercholesterolemia

On December 15, 2025, the FDA approved LIB Therapeutics’ lerodalcibep-liga (Lerochol) injection for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

The novel, third-generation PCSK9 inhibitor is self-administered as a once-monthly, single small-volume subcutaneous injection with extended room-temperature stability up to 3 months.

FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

On December 17, 2025, the FDA approved GSK’s depemokimab-ulaa (Exdensur) as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients ≥ 12 years of age. The decision was based on data from the phase 3 SWIFT-1 and SWIFT-2 trials showing sustained exacerbation reduction with 2 doses per year versus placebo, both plus standard of care.

FDA Approves Fibrinogen, Human-chmt (Fesilty) for Congenital Fibrinogen Deficiency

On December 19, 2025, the FDA approved Grifols’ fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia. The product will be commercialized in the US by Grifols and is expected to be available during the first half of 2026.

FDA Grants Breakthrough Device Designation to Holly Implantable Dialysis System

On December 15, 2025, the FDA granted Breakthrough Device Designation to Nephrodite’s Holly™ implantable, continuous dialysis system, recognizing Holly as a novel, transformative therapy addressing end-stage kidney disease. The designation was supported by data from a multi-day large animal study demonstrating sustained kidney function replacement with strong safety and performance outcomes.

Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

On December 18, 2025, Takeda announced positive topline results from a pair of phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe PsO. The Latitude studies demonstrated superiority of zasocitinib compared to placebo for the coprimary endpoints of static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 at week 16, with a significantly greater PASI 75 response rate observed as early as week 4 and continuing to increase through week 24. Of note, the studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast.