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EU regulators have refused to greenlight Eli Lilly’s weight loss drug Mounjaro as a treatment for a type of heart failure, while giving the go-ahead for Novo Nordisk’s semaglutide in liver disease. Lilly failed to get support from the European Medicines Agency’s human medicines committee, or CHMP, on Friday for Mounjaro to treat chronic heart failure with preserved ejection fraction in adults with obesity. HFpEF is when the heart becomes too stiff to pump enough blood around the body. The committee said Mounjaro didn’t reduce the number of patient deaths due to heart problems in patients with obesity and HFpEF. While the drug did reduce the number of heart failure-related hospitalizations, it’s unclear whether that was due to the weight loss-independent effect of Mounjaro, CHMP said. Lilly had also been angling after the heart failure label expansion in the US, but withdrew the application for Mounjaro — marketed as Zepbound for weight loss — from the FDA in May. Despite declining to expand Mounjaro’s label for heart failure, the committee said it would include the data from Lilly’s Phase 3 SUMMIT study in the drug’s product information. Meanwhile, Novo Nordisk won the panel’s go-ahead for semaglutide, branded as Kayshild, to be used as a treatment for patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis stages F2 to F3. Semaglutide is already available in the US to treat patients with MASH, after securing FDA approval in August. CHMP also gave positive opinions for four other new therapies: The agency also gave recommendations to extend the labels of nine therapies:

The EU's Committee for Medicinal Products for Human Use (CHMP) closed January with a slate of decisions Friday, including recommendations for Novo Nordisk and UCB drugs, while Sanofi's graft-versus-host disease (GvHD) treatment gets a second change and Eli Lilly settles for a label update.Novo Nordisk's KayshildOne of the more closely watched decisions was the conditional recommendation for Novo Nordisk's semaglutide to treat non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis, a new indication for the GLP-1 agonist that the company plans to market as Kayshild. Semaglutide is already approved for diabetes as Ozempic and Rybelsus, and as Wegovy for weight loss.The opinion marks the first time a GLP-1 agonist has been cleared in Europe for MASH, and comes about five months after US regulators approved it under the Wegovy brand for the same indication based on data from the Phase III ESSENCE trial. Results there showed that 37% of patients achieved improved liver scarring without their steatohepatitis getting worse at 72 weeks, compared to 22.5% on placebo. Rates of steatohepatitis resolution without any increase in liver scarring were 62.9% and 34.1%, respectively.Sanofi's Rezurock re-examinedAfter having revisited its October negative opinion of Sanofi's Rezurock (belumosudil) for chronic GvHD, the EU drug advisory panel now recommends conditional approval in last-line patients ages 12 years and up. The ROCK2 inhibitor downregulates IL-17 and IL-21 and mediates signalling in immune cellular function and fibrotic pathways.Sanofi picked up the oral ROCK2 inhibitor via its $1.9-billion Kadmon buyout in 2021, just after the FDA had cleared it for GvHD. In the pivotal Phase II ROCKstar study, the drug plus standard of care delivered about a 73% response rate in patients who had received two to five prior lines of systemic therapy, with a median duration of 1.9 months.At the time, CHMP said ROCKstar's single-arm design made it hard to clearly determine Rezurock's benefit, while Sanofi said it wouldn't have confirmatory data until 2030. Still, the French drugmaker requested a re-examination of the negative October decision, and said Friday's CHMP recommendation was based on safety and efficacy data "from several clinical studies and real-world evidence," including ROCKstar."We…made the commitment to conduct a new post-approval confirmatory study, given the limited late-line treatment options available for EU patients," said Olivier Charmeil, Sanofi's EVP of general medicines.UCB's KygevviCHMP also issued a positive opinion under exceptional circumstances for Kygevvi, UCB's treatment for thymidine kinase 2 deficiency, a rare and often fatal mitochondrial myopathy. It is indicated for patients whose disease started at or before 12 years of age. Kygevvi, which was approved by the FDA last November, works by incorporating the pyrimidine nucleosides, deoxycytidine and deoxythymidine, into skeletal muscle cell mitochondria to help rebuild their DNA.The EU recommendation relied on a retrospective chart review and a single-arm Phase II study in 39 children, in which 84% regained one or more motor milestones after treatment with Kygevvi, suggesting improved motor function. The most common side effects were diarrhoea, vomiting and abdominal pain.A recommendation under exceptional circumstances means the authorisation can be granted with specific obligations that are reviewed each year.Incyte's Zynyz expandedIn oncology, CHMP backed an extension for Incyte's PD-1–blocking antibody Zynyz (retifanlimab) to treat adults with inoperable, metastatic or locally recurrent squamous cell carcinoma of the anal canal (SCAC) when combined with chemotherapy. The drug was initially authorised in Europe in 2024 for Merkel cell carcinoma.US regulators greenlit Zynyz for SCAC last year based on results from the Phase III POD1UM-303 trial. According to CHMP, half of SCAC patients treated with Zynyz plus chemotherapy lived for 9.3 months or longer without their cancer worsening, versus 7.4 months for placebo and chemotherapy.However, regulators acknowledged lingering uncertainty over overall survival benefit; half of patients treated with Zynyz lived for at least 32.8 months compared with 22.2 months for placebo, which was not statistically significant. Still, the committee pointed to improvements in progression-free survival as sufficient evidence of clinical value in a setting with few alternatives.Lilly's Mounjaro for heart failureMeanwhile, not all GLP-1 news ended with CHMP backing. The EU panel declined to grant a separate heart-failure indication for Lilly's dual GLP-1/GIP agonist Mounjaro (tirzepatide) in patients with obesity and preserved ejection fraction (HFpEF), instead opting to incorporate trial results into the product label.The drug is currently approved in Europe for treating type 2 diabetes and for chronic weight management in adults. "Although EMA did not recommend that a separate indication should be granted for the treatment of HFpEF, it agreed to include relevant data from the study submitted with the application in the medicine's product information," CHMP said, so that "healthcare professionals have access to up-to-date data on the effects of Mounjaro in adults with chronic HFpEF and obesity."Lilly withdrew a similar application last year in the US, where tirzepatide is sold as Zepbound for weight loss, after the FDA asked to see more clinical data. The filing was based on Phase III data from the SUMMIT study showing that Zepbound reduced the risk of heart failure complications by 38% versus placebo in patients with and without diabetes.

MAHWAH, N.J.--(BUSINESS WIRE)-- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced that the Company received U.S. Food and Drug Administration (FDA) clearance for use of the KORU Medical FreedomEDGE® infusion system to deliver RYSTIGGO® (rozanolixizumab-noli), a therapy commercialized globally by UCB, Brussels, Belgium ( ). The clearance for the FreedomEDGE® label includes indicated administration by a healthcare professional, increasing flexibility and access for patients living with generalized myasthenia (gMG). RYSTIGGO® is a novel biologic approved to treat adults with generalized myasthenia gravis (gMG), a rare, chronic autoimmune disorder that affects communication between nerves and muscles.¹ RYSTIGGO® is administered as a weekly infusion of 3mL-6mL of drug over 15-30 minutes for 6 weeks, with subsequent treatment cycles based on clinical evaluation.¹ “With this new FDA clearance, we are proud to further our leadership in the rapidly growing large-volume subcutaneous infusion market, with our ninth subcutaneous drug clearance," said Linda Tharby, KORU Medical’s President and CEO. "Expanding from home administration into clinic-based care highlights the versatility of our Freedom Infusion System to deliver life-changing therapies wherever patients are treated. This clearance aligns with our strategy to extend the Freedom platform to more drug therapies, more settings, and more patients.” KORU Medical’s Freedom Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume from 5mL-50mL+, the Freedom System is market proven with: 15+ years of patient self-administration in the home 45,000+ patients and over 2M infusions annually 2 97% adherence rate 3 and 9 on-label subcutaneous drugs distributed across 30+ countries About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System (the “Freedom System”) currently includes the Freedom60® and FreedomEDGE® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HigH-Flo Subcutaneous Safety Needle Sets™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Pharma Service and Clinical Trials business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit . Trademark Statement RYSTIGGO® is a registered trademark of the UCB Group of Companies. References U.S. Prescribing Information: UCB, Inc. RYSTIGGO® (rozanolixizumab-noli) injection, for subcutaneous use – Prescribing Information . UCB, Inc.; Revised June 2023. Available at: . Accessed July 28, 2025. KORU Medical Estimates and Third-Party Data on File Rutland B, Bosshard J, Southworth C. Enhancing Drug Adherence and Patient Outcomes: The Role of SCIG Pump Selection in Subcutaneous Immunoglobulin Therapy for Primary Immunodeficiency Disease. Poster presented at: National Home Infusion Association Annual Conference; March 23-27, 2024; Austin TX. Contacts Investor Contact: Louisa Smith investor@korumedical.com