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EU Approves Pfizer’s Drug For Inflammatory Bowel Disease

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EU Approves Pfizer's Drug For Inflammatory Bowel Disease

(CTN News) – As reported by the company on Monday, the European Commission has approved Pfizer’s PFE.N drug, a controversial drug showing promise in the treatment of ulcerative colitis, a condition characterized by inflammation of the intestines, as a treatment option.

As announced in December by the European Medicines Agency, Velsipity has been approved by the organization’s panel of experts after it had been endorsed by the panel of experts of the organization in September.

According to a statement made by Pfizer,

The drug has been approved for use among people age 16 or older who have not responded satisfactorily to prior treatments or are intolerant of them, or those who have failed to respond adequately to previous treatments.

As a result of two late-stage studies Pfizer conducted in the European Union, the drug was approved for the use in all 27 countries that are part of the EU, based on the results of studies which demonstrated the drug’s effectiveness and safety in patients who met the criteria for eligibility for the treatment.

Earlier this year, Velsipity was approved as part of a class of drugs used to regulate the body’s immune response, and it is expected to compete with Bristol Myers Squibb’s BMY.N Zeposia, which was approved last year.

Among others, Pfizer has also sought regulatory approval for the drug in countries such as Australia, India and the United Kingdom, among others.

Earlier this year, Leerink Partners estimated that the Pfizer drug will generate $2.25 billion in sales by 2030.

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