ZEPOSIA

What it is

ZEPOSIA is an ozanimod capsule formulation sponsored by Bristol-Myers Squibb. The brand is available in two strength presentations: 230 microgram and 460 microgram capsules supplied in a blister wallet composite pack, and 920 microgram capsules supplied in a blister pack.

Approved indications

— Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.

Dosing overview

The pack containing 4 capsules of 230 micrograms and 3 capsules of 460 micrograms is available on the PBS. The 920 microgram capsule strength is also PBS listed.

Key safety warnings

No safety warnings are detailed in the provided source documents.

Contraindications

No contraindications are detailed in the provided source documents.

PBS listing

ZEPOSIA is listed on the PBS in two formulations: a pack containing 4 capsules of 230 micrograms and 3 capsules of 460 micrograms (2 PBS items, streamlined restriction, ex-manufacturer price A$488.84), and 920 microgram capsules (3 PBS items, authority required and streamlined restrictions, ex-manufacturer price A$1955.38). The latest schedule date is 2026-05-01.

Regulatory history

ZEPOSIA was first listed on the ARTG on 17 July 2020. The AusPAR approval date was 16 March 2022, with the indication for treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy. The PBAC recommended ZEPOSIA for ulcerative colitis (moderate to severe) in November 2022. In March 2024, the PBAC rescinded the March 2022 recommendation for ulcerative colitis.