HQ Team
February 20, 2024: Pfizer’s Velsipity, an oral drug to treat inflammatory bowel disease, got approval from the European Commission for patients aged 16 and above, according to a company statement.
The clearance for the drug for ulcerative colitis follows backing from the European Medicines Agency’s panel of experts in December. It is applicable in all the 27 nations of the union.
The backing from the experts came after studies from two late-stage trials that the drug was safe and effective, according to the statement.
It was approved for treatment in patients aged 16 or older who did not show adequate response or were intolerant to previous treatment.
Rectal bleeding, abdominal pain
Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease and clinical symptoms of the disease may include but are not limited to frequent diarrhoea, bowel urgency, rectal bleeding, abdominal pain, fatigue, fever and anaemia.
Its impact can span beyond the physical to other aspects of life due to the chronic and unpredictable nature of symptoms.
“For the 2.6 million people in Europe living with ulcerative colitis, the unpredictable physical, mental, and emotional impacts of the condition can be debilitating,” said Séverine Vermeire, MD, PhD, Professor of Medicine at KU Leuven.
“They may cycle through several different conventional treatment options to find relief for their symptoms.
“The approval of Velsipity helps bridge the gap for those with moderately to severely active ulcerative colitis who need an effective advanced treatment but may be apprehensive about using injectable therapies like biologics.”
The European Commission’s nod follows the drug’s approval for adults with moderately to severely active UC by the USFDA in October 2023 and in Canada in January 2024.
Regulatory applications for Velsipity in ulcerative colitis have been submitted to additional countries including Australia, India, Mexico, Russia, Singapore, Switzerland, Turkey, and the UK.
