EMA Panel Backs Two Breakthrough Treatments for Menopause and MASH

The European Medicines Agency's (EMA) expert panel has recommended two new treatments for approval. One targets menopausal symptoms, while the other addresses a severe liver condition, metabolic dysfunction-associated steatohepatitis (MASH). Both decisions follow reviews of clinical trial data and safety profiles.

The CHMP backed Fylrevy for hormone replacement therapy and Kayshild for MASH.

Fylrevy, developed by Gideon Richter, contains estetrol, a hormone designed to ease estrogen deficiency in postmenopausal women. Clinical trials showed it reduces the intensity and frequency of moderate to severe hot flashes. The drug will come in 14.2 mg and 18.9 mg film-coated tablets.

Common side effects include breast tenderness or pain. In women with an intact uterus, combining Fylrevy with progesterone may cause thickening of the uterine lining and bleeding. The CHMP's recommendation relies on two randomised, placebo-controlled studies, with no further long-term data published by January 2026.

Meanwhile, Novo Nordisk's Kayshild received conditional approval for treating MASH in adults without cirrhosis. The injectable medication, used alongside diet and exercise, will be available in prefilled pens with doses ranging from 0.25 mg to 2.4 mg.

Neither treatment has yet been reviewed by independent bodies like the WHO or the American Menopause Society. The CHMP's decisions mark the first regulatory steps toward wider availability in Europe.

Fylrevy and Kayshild now move closer to market release after the CHMP's positive assessments. Fylrevy offers a new option for managing menopausal symptoms, while Kayshild provides a treatment path for MASH patients. Both drugs will require further monitoring as they enter clinical use.