Pfizer’s ulcerative colitis drug Velsipity gets EU okay

The European Commission has approved Pfizer’s S1P receptor modulator Velsipity as a treatment for ulcerative colitis (UC), raising the pressure on Bristol-Myers Squibb’s first-to-market Zeposia.

Velsipity (etrasimod) has been cleared in the EU to treat patients aged 16 years and over with moderate-to-severe active UC who haven’t responded to or cannot tolerate other treatments, a few months after it was cleared for the same indication by the FDA. The drug was also approved in Canada last month.

Pfizer is playing catch-up in the UC market with Velsipity, as Zeposia (ozanimod) has been approved for that indication since 2021 and has been used to treat multiple sclerosis since 2020. BMS’ drug has started to gather momentum after a somewhat slow start, with sales rising 74% to $434 million last year.

In UC, both drugs are seen as a bridge between conventional treatment with aminosalicylates, corticosteroids, or JAK inhibitors and injectable therapies like TNF inhibitors.

Pfizer has emphasised that Velsipity is the only drug approved to treat patients aged 16 and over – Zeposia’s label covers only use in adults – and has said it offers a “favourable benefit-risk profile.”

The EU approval is based on results from the ELEVATE UC clinical trials programme, which found a clinical remission rate of 32% after 52 weeks compared to 7% for placebo, along with improvements on secondary measures, including the total inflammatory bowel disease questionnaire score, which measures health-related quality of life.

Pfizer also points to the fact that its trials are the only studies of advanced therapies for UC to include patients with isolated proctitis, which affects approximately 30% of those diagnosed with UC and involves inflammation of the rectal mucosa.

Velsipity was the cornerstone of Pfizer’s $6.7 billion acquisition of Arena Pharmaceuticals, which completed in 2022. The company recorded a $1.4 billion impairment charge in its fourth-quarter 2023 earnings in connection with the drug, “based on a change in development plans for additional indications and overall revenue expectations.”

In the update, chief business and innovation officer Aamir Malik said that, while the clinical profile pf Velsipity is “very, very strong," the company is not expecting sales to ramp up quickly.

“[I] want to remind you that, with any immuno-inflammatory product, it takes time to get broad national access,” he told investors. “Our focus […] right now is ensuring that we secure Velsipity access as a first-line advanced therapy oral option, and that’s going to take some time to put in place.”