Novo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval

A key European regulatory advisory committee has recommended Novo Nordisk’s once-weekly injectable diabetes treatment Kyinsu (insulin icodec / semaglutide) for approval.

The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) 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 a full approval from the European Commission within three months, at which point Kyinsu would be made available as a pre-filled pen injection (700 U/ml / 2 mg/ml solution) for use as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products.

The committee’s positive opinion of Novo Nordisk’s Kyinsu is based on three Phase III clinical studies showing the combination drug provided a clinically relevant effect on glycaemic control in these patients.

Supporting future market growth of diabetes and obesity therapies

Novo has recently been struggling with the “increased organisational complexity and costs” created by increased competition for its blockbuster semaglutide in the lucrative obesity market, where it operates under the Wegovy brand.

Earlier this month the company confirmed some steep cuts to its workforce in a bid to “invest more behind its science, commercial capabilities and manufacturing ramp-up.” Nine thousand jobs are expected to go, with around 5,000 of those positions located in Denmark.

Yet there is still potential for further market growth. The European recommendation for Novo’s Kyinsu adds to positive news for its semaglutide component. Ozempic (once-weekly injectable semaglutide) was recently found to reduce the risk of heart attack, stroke and death by 23 percent in its first head-to-head study with Lilly’s Trulicity (dulaglutide).

Improving sleep disturbance and quality of life during menopause

The CHMP also gave a positive opinion to the use of Bayer’s Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms (hot flushes).

The non-hormonal neurokinin 1 (NK-1) and 3 (NK-3) receptor antagonist is available as 60mg soft capsules and helps to normalise neuronal activity involved in thermo- and sleep regulation in the hypothalamus, supporting the reduction of menopause-related symptoms.

Hot flushes are typically associated with two different conditions, menopause and vasomotor symptoms caused by adjuvant endocrine therapy.

As such two Phase III studies assessed the efficacy of Lynkuet in post-menopausal woman, and another evaluated its capabilities in women with, or at high risk for developing, hormone-receptor-positive breast cancer. All three demonstrated a reduction in the frequency of moderate to severe vasomotor symptoms, with additional improvements seen in sleep disturbances and menopausal quality of life.