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Novo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval
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News - European Pharmaceutical Review
Novo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval0 SHARESPosted: 22 September 2025 | Catherine Eckford (European Pharmaceutical Review) |EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
A key European regulatory advisory committee has recommended Novo Nordisk’s once-weekly injectable diabetes treatment Kyinsu (insulin icodec / semaglutide) for approval.
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.
Hot flushes are typically associated with two different conditions, menopause and vasomotor symptoms caused by adjuvant endocrine therapy.
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.
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