Zealand Pharma gets CHMP nod for glepaglutide in short bowel syndrome

The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.

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Zealand Pharma has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorisation for Zeydovio (glepaglutide) as a treatment for short bowel syndrome (SBS) in adults. The European Commission will now review the opinion, with a final decision expected within approximately 67 days. If approved, the authorisation would cover all EU member states as well as Iceland, Liechtenstein, and Norway.

Glepaglutide is a long-acting GLP-2 analogue administered twice weekly via a ready-to-use autoinjector. The drug works by improving intestinal absorption, reducing or, in some patients, eliminating the need for parenteral support. SBS is a rare, chronic condition in which patients lose sufficient intestinal function to require intravenous nutrition and fluids, often for life. Long-term parenteral support carries serious risks including sepsis, blood clots, liver damage, and renal impairment.

Trial data

The CHMP opinion draws primarily on results from the pivotal EASE-1 Phase 3 trial, a randomised, double-blind study in 106 patients with SBS and intestinal failure who were dependent on parenteral support for at least three days per week. At 24 weeks, twice-weekly glepaglutide reduced total weekly parenteral support volume by 5.13 litres compared with 2.85 litres in the placebo group (p=0.0039). Among patients on the twice-weekly dose, 65.7% achieved the clinical response threshold of at least a 20% reduction in weekly parenteral support volume, against 38.9% in the placebo group. Nine patients treated with glepaglutide achieved enteral autonomy, meaning they were weaned off parenteral support entirely; no placebo-treated patients did so.

The opinion was further supported by interim data from the EASE-2 and EASE-3 long-term extension trials, which ran for up to two years, and by EASE-4, a mechanistic Phase 3b trial demonstrating pharmacodynamic improvements in intestinal absorption. Full results from EASE-2 and EASE-3 are expected to be presented at scientific meetings in 2027.

David Kendall, Chief Medical Officer of Zealand Pharma, said the drug's twice-weekly autoinjector dosing "holds potential as a transformative therapy for SBS that could meaningfully ease the burden of disease management for thousands of patients."

Market context and US path

SBS is a small but high-burden rare disease market. The principal comparator in Europe is teduglutide (Revestive, marketed by Takeda following its acquisition of Shire), also a GLP-2 analogue, which received European approval in 2012. A positive CHMP opinion for glepaglutide represents the first new treatment recommendation in the indication in Europe in more than a decade. Zealand Pharma has not yet named a commercial partner for European launch and says it is actively engaged in partnering discussions.

In the United States, the company is running the randomised, placebo-controlled Phase 3 EASE-5 trial to generate the confirmatory dataset needed for a New Drug Application submission. The FDA has already granted orphan drug designation for glepaglutide in SBS, a designation that carries seven years of market exclusivity upon approval and may prove meaningful in a field where patient populations are limited. Investors will be watching the EASE-5 recruitment pace and the timing of any partnership announcement as the key near-term catalysts.

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