EMA recommends approval of six medicines, expands indications for nine

EMA’s human medicines committee (CHMP) published the outcomes of their meeting on Friday (30 January). EMA recommended six medicines for approval at its meeting and extended the therapeutic indications of nine medicines.

Here are some highlights:

Menopause: The committee recommended marketing authorisation for Fylrevy (estetrol),  a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women who have had a hysterectomy, made by Hungarian company Gedeon Richter Plc.

GR’s Head of Women’s Healthcare (WHC), Dr Péter Turek, Business Unit, said that it was an important milestone, saying it may be the first innovative hormonal therapy for menopause in the European market in decades. 

“Bringing an original product to the market – our second, based on the unique, proprietary Estetrol platform – would be a major achievement for Richter. It reflects our unwavering commitment to improving the quality of life of women globally, validates our strategy to invest in original research, and further strengthens our leading position in Europe.”

Cancer: Use of Zynyz in the treatment of anal cancer has been extended, though trial results show no “statistically meaningful” difference in life prolongation. Despite the uncertainty about the extent to which Zynyz prolongs life, EMA concluded that data on how long patients lived without their cancer worsening indicated a beneficial effect.

Rare disease: The CHMP approved the first treatment for thymidine kinase 2 deficiency (TK2d) a rare, life-threatening genetic disease that affects fewer than one in a million people and for which there is no authorised treatment. The medicine was supported through EMA's PRIority MEdicines (PRIME) scheme.

UCB said the positive decision marked a turning point in treatment.

“We are deeply proud to be one step closer to being able to bring the first and only approved treatment for TK2d to the community,” said UCB’s Chief Medical Officer Donatello Crocetta. 

GLP-1: EMA did not approve a new indication for Lilly’s GLP-1 (tirzepatide) Mounjaro to include treatment of symptomatic long-term (chronic) heart failure with preserved ejection fraction (HFpEF) in adults. The CHMP concluded that no separate indication should be granted, while relevant study data will be added to the product information to inform healthcare professionals about its effects in adults with HFpEF and obesity.

By contrast, Novo Nordisk’s GLP-1 Kayshild (semaglutide, think Ozempic and Wegovy) was granted conditional marketing authorisation for the treatment of MASH, a form of fatty liver disease, which leads to the build-up of fat, ultimately causing fibrosis. Full approval will be given once additional evidence is provided confirming a medicine’s benefits. 

Auto-immune disease: The committee has launched a review of Tavneos (avacopan) after concerns emerged about the integrity of data from its main supporting study, the review was requested by the European Commission. Tavneos is approved for treating adults with severe, active granulomatosis with polyangiitis (also known as Wegener’s disease).

New medicines:

Extension of therapeutic indication of existing medicines: