Pfizer breaks new ground with PBS listing of ulcerative colitis drug

Pharma News: Pfizer Australia has announced the reimbursement of its oral S1P receptor modulator on the Pharmaceutical Benefits Scheme (PBS) for the treatment of moderate-severe active ulcerative colitis (UC).

Velsipity (etrasimod) is indicated for adults who have had an inadequate response, loss of response, or intolerance to conventional, biologic, or Janus kinase (JAK) inhibitor therapies. The PBS listing of Velsipity underscores the importance of Pfizer’s $6.7 billion acquisition of Arena Pharmaceuticals.

Ulcerative colitis, a chronic inflammatory condition of the colon (bowel), impacts an estimated 100,000 Australians, with this figure projected to rise in the coming years.

Leanne Raven, Chief Executive Officer of Crohn’s and Colitis Australia, highlighted the challenges UC patients face.

“Living with ulcerative colitis can have an unpredictable and challenging life-long impact, where symptoms can flare up at any given moment, significantly impacting quality of life,” she explained.

Raven welcomed the PBS listing, adding, “It’s encouraging to see treatments like Velsipity listed on the PBS, providing another subsidised treatment option for those who need it.”

As a direct competitor to Bristol-Myers Squibb’s (BMS) Zeposia (ozanimod), which was PBS-listed in May 2023, Velsipity offers a new alternative for patients. In clinical trials, the drug has shown promising results: in the ELEVATE UC52 study, Velsipity helped 27% of patients achieve remission by week 12, compared to 7.4% in the placebo group. By week 52, 32% of patients on Velsipity were in clinical remission, versus 6.7% on placebo.

Although Velsipity carries the same warning on bradyarrhythmia as Zeposia, requiring patients to undergo an ECG before starting treatment, it offers an advantage with no need for dosing titration.

Anne Harris, Managing Director of Pfizer Australia and New Zealand, expressed the company’s dedication to improving patient outcomes.

“At Pfizer, we are committed to developing breakthroughs that change patients’ lives. The PBS listing of Velsipity provides people living with this chronic and debilitating condition, and the clinicians who treat them, with affordable and equitable access to an important additional treatment option to help manage their disease,” she stated.

Looking ahead, Pfizer is eyeing further indications of Velsipity, aiming to extend its use to other autoimmune diseases, including Crohn’s disease.

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