Pfizer gets EU approval for $2.2bn bowel disease drug

It is estimated sales of the drug could total €2bn

Pfizer employs almost 5,000 people at sites in Kildare, Cork, and Dublin.

Pfizer's drug to treat patients with an inflammatory bowel disease called ulcerative colitis has been approved by the European Commission, the company said. 

The approval for Velsipity follows backing from the European Medicines Agency's panel of experts in December. It is estimated sales of the drug could total $2.2bn (€2bn). Pfizer employs almost 5,000 people at sites in Kildare, Cork, and Dublin.  

The drug was approved for use in patients aged 16 or older and who did not show adequate response or were intolerant to previous treatment, Pfizer said.

The approval, applicable in all 27 countries of the European Union, is based on studies from two late-stage trials that showed the drug was effective and safe in eligible patients.

About 2.6 million people in Europe are living with ulcerative colitis, Pfizer says.

The company did not immediately respond to a request for detail on pricing and availability of the drug.

Velsipity, which was approved in the US in October, belongs to a class of drugs used to regulate the body's immune response and is expected to compete with Bristol Myers Squibb's Zeposia.

Pfizer has also sought regulatory approvals for the drug in Australia, India, and the UK, among others.

Leerink Partners in October estimated the drug's 2030 sales at $2.2bn. 

• Reuters