2024-02-20 10:30:00
Ulcerative Colitis, Pfizer announces marketing approval for etrasimod (VELSIPITY®) from the European Commission
Pfizer announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union, for the treatment of patients aged 16 years and older with Ulcerative colitis (UC) moderately to severely active, who have had an inadequate response, lost response or were intolerant to conventional therapy or a biologic.
“For the 2.6 million people in Europe living with UC, the unpredictable physical, mental and emotional impacts of the disease can be debilitating. They can go through several conventional treatment options to relieve the symptoms“, he has declared Séverine VermeireMD, PhD, Professor of Medicine at the KU Leuven and researcher ELEVATE Registrational Program. “The approval of VELSIPITY® helps fill the gap for people with moderate to severe UC who need effective advanced treatment but who may be concerned about using injectable therapies such as biologics“.
The marketing authorization for VELSIPITY® is valid in all 27 EU member statesin Iceland, Liechtenstein e Norway. The authorization follows the approval recommendation of theEuropean Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023. It also follows the approval of VELSIPITY® for adults with moderate to severe UC by the Food and Drug Administration (FDA) in October 2023, and for adults with moderately to severe UC who have had an inadequate response, lost response, or are intolerant to conventional therapy or advanced treatment in Canada in January 2024. Applications for VELSIPITY® in the UC have been presented to other countries around the world for examination.
“VELSIPITY® can help UC patients who struggle to achieve remission with conventional therapies“, he has declared Alexandre de GermayChief International Commercial Officer, Executive Vice President of Pfizer. “With convenient once-daily oral dosing and a favorable benefit-risk ratio, VELSIPITY® represents an attractive treatment option and Pfizer is proud to bring this drug to UC patients aged 16 years and older in the European Union“.
Approval is based on the results of theELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12), which evaluated the safety and efficacy of VELSIPITY® 2 mg once daily on clinical remission in UC patients who have previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
Furthermore, ELEVATE UC 52 ed ELEVATE UC 12 they were the only studies of advanced therapies for UC to include patients with isolated proctitis, which affects about 30% of people diagnosed with UC. Both studies achieved all the endpoint primary and secondary efficacy, with a favorable safety profile, in line with previous studies on VELSIPITY®. VELSIPITY® it also demonstrated an improvement in the total score of the inflammatory bowel disease questionnaire, which measures health-related quality of life. The most common adverse reactions were lymphopenia (11%) and headache (7%).
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