Pfizer's Velsipity Approved for Active Ulcerative Colitis in Europe

Pfizer Inc. received marketing approval. Velsipiti (ethrasimod) in the European Union for the treatment of patients with mild to severe ulcerative colitis (UC) did not respond adequately if there is no response to current therapies or biologics.

“For the 2.6 million people in Europe living with UC, the sudden physical, mental and emotional consequences of the disease can be devastating. Many current treatments can be cycled to relieve symptoms," says Dr. Séverine Vermeire, professor of medicine at KU Leuven and supervisor of the ELEVATE registry project. "The approval of Velsifity will help close the gap for patients with moderate to severe. Ulcerative colitis who require advanced treatment but may be concerned about the use of injectable therapies such as biologics."

Velsipity's marketing authorization is valid in 27 EU member states, including Iceland, Liechtenstein and Norway. This agreement follows the recommendation for approval in December 2023 by the EMA (European Medicines Agency) for Medicines for Human Use (CHMP). In addition, Velcipity has been approved by the US. 

Food and Drug Administration (FDA) for adults with moderate to severe ulcerative colitis. (FDA) in October 2023, and will be approved in Canada in January 2024 for adults with moderate to severe ulcerative colitis who have had an inadequate response, lost response, or are unresponsive to previous or previous treatments. The legal coverage of Velsipity in UC is as follows: It has been sent to other countries worldwide for review.

"Velsipity can provide needed assistance to patients with ulcerative colitis who can achieve remission with current treatments," said Alexandre de Germay, director of global marketing and senior vice president of Pfizer. "With the convenience of daily oral administration and benefits information, Velsipity is an attractive treatment option. Pfizer is proud to offer this medicine to patients with ulcerative colitis, a 16-year-old in the European Union."