The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for Novo Nordisk's once-weekly injectable diabetes treatment Kyinsu (insulin icodec/semaglutide), marking a significant regulatory milestone for the Danish pharmaceutical company's combination therapy approach to type 2 diabetes management.
Regulatory Pathway and Approval Timeline
The CHMP's positive opinion covers Kyinsu's use in adults with type 2 diabetes mellitus whose disease is insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists. CHMP recommendations typically translate into full approval from the European Commission within three months, positioning Kyinsu for market entry across European Union member states.
Upon approval, Kyinsu would be made available as a pre-filled pen injection containing 700 U/ml insulin icodec and 2 mg/ml semaglutide solution. The treatment is intended for use as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products.
Clinical Evidence Supporting Approval
The committee's positive opinion is based on three Phase III clinical studies that demonstrated Kyinsu provided clinically relevant effects on glycemic control in the target patient population. The combination therapy leverages the complementary mechanisms of insulin icodec, a long-acting basal insulin, and semaglutide, a GLP-1 receptor agonist that has shown significant efficacy in diabetes management.
The weekly dosing schedule represents a potential advancement in patient convenience compared to daily insulin regimens, potentially improving treatment adherence in patients with type 2 diabetes who require intensified therapy beyond oral medications alone.
Market Context and Competitive Landscape
The regulatory progress comes as Novo Nordisk faces increased organizational complexity and costs due to heightened competition for its blockbuster semaglutide in the obesity market, where it operates under the Wegovy brand. The company recently announced plans to cut 9,000 jobs, with approximately 5,000 positions located in Denmark, as part of efforts to invest more behind its science, commercial capabilities, and manufacturing ramp-up.
Despite these challenges, there remains potential for market growth in diabetes therapeutics. Recent data showed that Ozempic (once-weekly injectable semaglutide) reduced the risk of heart attack, stroke, and death by 23 percent in its first head-to-head study with Eli Lilly's Trulicity (dulaglutide), supporting the continued clinical value of semaglutide-based therapies.
Additional CHMP Recommendations
The CHMP also issued a positive opinion for Bayer's Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms, specifically hot flushes associated with menopause. The non-hormonal neurokinin 1 (NK-1) and 3 (NK-3) receptor antagonist is available as 60mg soft capsules and works by normalizing neuronal activity involved in thermo- and sleep regulation in the hypothalamus.
Three Phase III studies supported Lynkuet's approval recommendation, with two assessing efficacy in post-menopausal women and another evaluating capabilities in women with, or at high risk for developing, hormone-receptor-positive breast cancer. All three studies demonstrated reductions in the frequency of moderate to severe vasomotor symptoms, with additional improvements observed in sleep disturbances and menopausal quality of life.
