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EU panel backs Zealand Pharma's short bowel syndrome drug Zeydovio

EU panel backs Zealand Pharma's short bowel syndrome drug Zeydovio

New Capabilities

CHMP recommendation sends glepaglutide to the European Commission for a final decision expected within about 67 days

2 days ago: Zealand Pharma announces CHMP recommendation

Overview

Updated 1 hour ago

Zealand Pharma's Zeydovio is one step from market in Europe. On September 17, the European Medicines Agency's scientific committee recommended approving the twice-weekly injection for adults with short bowel syndrome.

In a Phase 3 trial, two-thirds of treated patients cut their weekly IV nutrition volume by at least 20%, and one in seven stopped needing it entirely. The European Commission has about 67 days to grant final approval across the 27 EU states plus Iceland, Liechtenstein, and Norway.

Why it matters

It would be Europe's first new short bowel syndrome treatment in over a decade, and could free patients from daily IV nutrition.

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Key Indicators

65.7%
Clinical response rate
Patients cutting weekly parenteral support by ≥20% at 24 weeks, vs 38.9% for placebo in EASE-1.
14%
Patients who stopped IV support entirely
In the twice-weekly glepaglutide group; no placebo patients achieved enteral autonomy.
5.13 L/week
Mean reduction in weekly parenteral support volume
vs 2.85 L/week for placebo (p=0.0039) in the EASE-1 trial.
67 days
Expected time to European Commission decision
Commission normally issues its decision within 67 days of the CHMP opinion.
106
Patients in the EASE-1 Phase 3 trial
Randomized to glepaglutide 10 mg once or twice weekly, or placebo.

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People Involved

Organizations Involved

Timeline

November 2024 September 2026

3 events Latest: 2 days ago
  1. Zealand Pharma announces CHMP recommendation

    Latest Corporate

    Company disclosed the positive opinion, reported efficacy data from EASE-1, and said partnership talks for global commercialization are underway.

  2. CHMP adopts positive opinion for Zeydovio

    Regulatory

    The EMA's Committee for Medicinal Products for Human Use recommended marketing authorization for glepaglutide to treat short bowel syndrome.

  3. US FDA delivers setback to glepaglutide

    Regulatory

    About two years before the CHMP opinion, the US Food and Drug Administration rejected glepaglutide, pushing Zealand to focus on Europe and a confirmatory US trial.

Scenarios

1

European Commission grants Zeydovio marketing authorization

Likely Resolves by Dec 15, 2026

Discussed by: Zealand Pharma and EMA statements

CHMP positive opinions are nearly always followed by a Commission decision within about 67 days. Approval would make Zeydovio marketable across the EU plus Iceland, Liechtenstein, and Norway, and Zealand would then line up a commercial partner to launch.

2

Zealand Pharma signs global commercialization partnership

Possible Resolves by Q2 2027

Discussed by: Reuters; Zealand CEO Adam Steensberg

Steensberg said the company will step up negotiations to find a global commercial partner responsible for the drug's launch in Europe and the US. A deal would fund commercial infrastructure and the ongoing EASE-5 trial supporting a US application.

3

EASE-5 trial clears path to US approval

Uncertain Resolves by End of 2027

Discussed by: Zealand Pharma

Zealand is enrolling the Phase 3 EASE-5 trial to support a US New Drug Application after the earlier FDA rejection. Confirmatory results could reverse the US's stance on glepaglutide, but the trial timeline and FDA's position are uncertain.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

September 2012

Teduglutide (Revestive) EU approval (2012)

The European Commission approved teduglutide, the first GLP-2 analog, for short bowel syndrome. It was a breakthrough, the first drug shown to help patients reduce their dependence on IV nutrition, but it required daily subcutaneous injections.

Then

Teduglutide became the standard add-on therapy for SBS across Europe.

Now

It validated the GLP-2 mechanism and opened the field for longer-acting analogs.

Why this matters now

Zeydovio uses the same mechanism with a longer half-life, given twice weekly instead of daily, which is the improvement that could broaden who benefits.

late 2024

US FDA rejection of glepaglutide (2024)

About two years before the CHMP opinion, the US Food and Drug Administration rejected Zealand Pharma's glepaglutide, a setback that redirected the company toward European approval first.

Then

Zealand focused on its EU filing and launched the confirmatory EASE-5 trial for the US.

Now

The divergence leaves the US, the largest SBS drug market, behind Europe on access to Zeydovio.

Why this matters now

The EU recommendation now puts Europe ahead of the US on this treatment, with the EASE-5 outcome set to determine whether the US eventually follows.

Sources

(6)