Novo Nordisk’s Kyinsu for Type 2 Diabetes
Drug approvals in Europe have gained major momentum as the CHMP issued a series of positive recommendations across multiple therapeutic areas this month. A year after Novo Nordisk withdrew its U.S. application for IcoSema as a treatment for type 2 diabetes, the company has gained support for the combination therapy in Europe. The Committee for Medicinal Products for Human Use (CHMP) has recommended once-weekly Kyinsu, the European name for the therapy, for patients with type 2 diabetes who cannot adequately control blood sugar with basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists.
Kyinsu combines insulin Awiqli (icodec), administered once weekly, with the GLP-1 treatment Ozempic (semaglutide). In July of last year, the U.S. Food and Drug Administration (FDA) rejected icodec for type 1 and type 2 diabetes, citing issues with its “manufacturing process.” A panel of experts also voted 7-4 against recommending it for type 1 diabetes because of concerns about low blood sugar risk. The rejection came three months after the European Medicines Agency (EMA) granted Awiqli marketing authorization for type 1 and type 2 diabetes, following a favorable CHMP opinion.
Bayer’s Lynkuet for Menopause Symptoms
In other actions, the CHMP recommended Bayer’s Lynkuet (elinzanetant) for approval to treat moderate-to-severe hot flashes or night sweats associated with menopause. The drug targets NK-3 and NK-1 receptors. Both the UK and Canada approved the therapy in July, while the FDA postponed its decision until October 26. With approvals in Europe and the U.S., Bayer would become the second company, after Astellas to offer a hormone-free option for this condition.
Other Key Recommendations
The CHMP also issued a positive opinion on Merck’s monoclonal antibody Enflonsia to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants. The treatment was approved by the FDA in June and will compete with AstraZeneca and GSK’s Beyfortus.
Johnson & Johnson’s Imaavy received CHMP backing for the treatment of generalized myasthenia gravis, five months after FDA approval in the same indication.
Cosmo Pharmaceuticals’ topical acne treatment Winlevi gained a positive opinion after a re-examination, reversing a previous negative decision. Meanwhile, Amgen’s Uplizna was endorsed as a therapy for immunoglobulin G4-related disease (IgG4-RD), following FDA approval earlier this year.
Merck’s Keytruda Gains Double Recommendation
Merck secured two CHMP recommendations for Keytruda. The first supports approval of a subcutaneous formulation across all adult indications in Europe. “The recommendation applies to all approved adult indications in Europe,” the CHMP stated. The second opinion favors its use in locally advanced head and neck squamous cell carcinoma, three months after FDA approval.
Additional CHMP-Backed Treatments
Further recommendations included Regeneron and Sanofi’s Dupixent for chronic spontaneous urticaria, Hipra Human Health’s Bimervax as a COVID-19 booster for individuals 12 and older who have previously received an mRNA vaccine, AstraZeneca’s Tezspire for chronic rhinosinusitis with nasal polyps, and AstraZeneca’s Koselugo for inoperable plexiform neurofibromas in patients with neurofibromatosis type 1 aged three and older.
These CHMP decisions may shift the competitive landscape in diabetes, menopause, immunology, and oncology. For Novo Nordisk, the Kyinsu recommendation marks a resurgence of its commitment to advanced drug innovation in metabolic disease, especially after the U.S. withdrawal. Concurrently, companies with drugs endorsed now must navigate cost, reimbursement, and comparative efficacy to convert CHMP support into commercial success.
Looking ahead, the European Commission is expected to formalize approvals based on these CHMP opinions, likely within three months for many cases. The drug candidates now enter the final regulatory stretch, where real-world safety, scale manufacturing, and reimbursement strategy will determine their fate. For patients and advocates, the broad sweep of CHMP support signals a turning point: regulators appear primed to fuel access to innovative therapies. As these drug endorsements evolve into market launches, every stakeholder—from clinicians to payers—will be watching how these new treatments perform in real-world settings.
