PFIZER’S drug to treat patients with an inflammatory bowel disease called ulcerative colitis has been approved by the European Commission, the company said on Monday (Feb 19).
The approval for Velsipity follows backing from the European Medicines Agency’s panel of experts in December.
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.
Pfizer said Velsipity will be available in each of the member countries after the national processes are complete, including applications for reimbursement for the drug.
About 2.6 million people in Europe are living with ulcerative colitis, Pfizer says.
Velsipity, which was approved in the United States 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 US$2.2 billion.
