Six New Approvals and Nine Indication Extensions from EMA’s CHMP

The European Medicines Agency (EMA) concluded its January 2026 meeting with the Committee for Medicinal Products for Human Use (CHMP) recommending six new medicines for marketing authorization.¹ These recommendations highlight a significant shift in therapeutic landscapes, particularly in the areas of metabolic health and specialized radiopharmaceuticals.

A notable recommendation was granted for Kayshild, a semaglutide formulation from Novo Nordisk A/S, which serves as a GLP-1 receptor agonist.¹ While several GLP-1s are currently authorized for weight management and diabetes, this marks the first approved for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis. This approval signalizes a broadening market for metabolic therapies, as fat accumulation in the liver causing inflammation represents a serious disease with evolving clinical needs.

The committee also issued a positive opinion for Ilumira, a radiopharmaceutical precursor developed by SHINE Europe B.V.¹ From a manufacturing and labeling perspective, Ilumira requires strict adherence to specific development protocols, as the EMA stated that "Ilumira must be used only for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride."

In the realm of rare diseases, UCB Pharma received a positive opinion under exceptional circumstances for Kygevvi, intended for thymidine kinase 2 deficiency.² This designation is critical for biopharma organizations focusing on unmet needs, as "the CHMP adopted a positive opinion under exceptional circumstances for Kygevvi (doxecitine / doxribtimine), the first treatment for thymidine kinase 2 deficiency, a rare, life-threatening genetic disease that affects fewer than one in a million people and for which there is no authorised treatment." The development was facilitated through the Priority Medicines scheme, which offers enhanced regulatory support for promising candidates.

Other recommendations included Supemtek, a trivalent recombinant influenza vaccine from Sanofi Winthrop Industrie, which utilizes cell culture preparation rather than traditional methods.¹ Additionally, Gedeon Richter Plc. received a recommendation for Fylrevy (estetrol), which the EMA described as "a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women."¹

How Are Therapeutic Indications Expanding for Existing Medicines?

The January meeting also resulted in nine recommendations for extending therapeutic indications, reflecting the ongoing lifecycle management and utility expansion of authorized products.¹ These extensions often require adjustments to production volumes or new delivery formats to accommodate broader patient populations.

One such expansion involves Zynyz, a retifanlimab treatment from Incyte Biosciences Distribution B.V.³ The committee recommended its use for squamous cell carcinoma of the anal canal, a condition for which no specific medicines were previously authorized in the European Union (EU). Similarly, Alk-Abello A/S received a positive opinion for a new 1 mg nasal spray strength of Eurneffy, providing a non-injectable alternative for children weighing between 15 kg and 30 kg who face allergic reactions.¹

Following a re-examination, CHMP also recommended a conditional marketing authorization for Rezurock, a Sanofi Winthrop Industrie product for chronic graft-versus-host disease.⁴ The regulatory guidance for this medicine is specific: "the committee concluded that this medicine is to be used when other treatment options provide limited clinical benefit, are not suitable or have been exhausted."

Regarding Mounjaro, an Eli Lilly Nederland B.V. product, the EMA reviewed an application to include the treatment of heart failure with preserved ejection fraction in adults with obesity.¹ While a separate indication was not granted, the committee agreed to include the relevant study data in the product information. This decision ensures that healthcare professionals can access data on the effects of the medicine in this specific population, highlighting the importance of clinical data integration even when label expansions are not fully realized.

Why Has a Regulatory Referral Been Initiated for Data Integrity Concerns?

Maintaining market authorization is contingent upon the continuous integrity of clinical data, a principle underscored by a new referral procedure involving Tavneos.⁵ The review was requested by the European Commission under Article 20 of Regulation (EC) No 726/2004.

According to the committee, "the committee started a review of Tavneos (avacopan), following emerging information that raises questions regarding the data integrity of the main study supporting the medicine’s marketing authorisation in the EU." This serves as a professional reminder that regulatory bodies maintain active oversight post-authorization, and any discrepancies in the underlying study data can lead to a formal re-evaluation of a medicine's status in the EU market.

References

1. EMA. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 26-29 January 2026. Press release. Jan 30, 2026.
2. EMA. First Treatment for Rare Thymidine Kinase 2 Deficiency. Press release. Jan 30, 2026.
3. EMA. First Immunotherapy-Based Treatment Recommended for Advanced Anal Cancer. Press release. Jan 30, 2026.
4. EMA. New Medicine to Treat Chronic Graft-Versus-Host Disease. Press release. Jan 30, 2026.
5. EMA. EMA Starts Review of Tavneos, a Medicine for Rare Autoimmune Diseases GPA and MPA. Press release. Jan 30, 2026.