UCB submits marketing application in Europe for Cimziatm for Crohn's disease

By E. Janene Geiss

Philadelphia, April 28 - UCB announced Thursday the submission of a Marketing Authorization Application to the European Medicines Agency for the approval of Cimziatm (certolizumab pegol, CDP870) to treat patients with Crohn's disease.

When approved, Cimzia will represent the first biologic administered by monthly subcutaneous injection as a treatment for Crohn's disease patients, according to a company news release.

The European submission follows the filing of a Biologics License Application for Cimzia to the Food and Drug Administration on March 1, officials said.

The European submission is based on safety and efficacy data from more than 1,500 patients with Crohn's disease. The two pivotal phase 3 studies that support the European application submission met their primary endpoints with statistical significance, demonstrating Cimzia's sustained and consistent efficacy in patients with Crohn's disease, officials said.

The Cimzia submission represents the largest biologic clinical trial database submitted to the EMEA for Crohn's disease treatment.

The phase 3 studies also represent the broadest clinical trial program, in terms of patient type, in Crohn's disease, encompassing patients with previous exposure to an anti-TNF treatment with a range of concomitant therapies and variable duration of disease, officials said.

Cimzia offers monthly dosing and a subcutaneous route of administration, officials said.

"There is a definite need for new therapies, allowing physicians more options for providing effective long-term relief from the significant burden of this debilitating disease," Paul Rutgeerts, professor of medicine at the Katholieke Universiteit Leuven in Belgium, said in the release.

In addition to the current development program in Crohn's disease, ongoing studies are investigating the efficacy and tolerability of Cimzia in the treatment of rheumatoid arthritis and psoriasis, officials said.

UCB is a Brussels, Belgium, biopharmaceutical company dedicated to the development and commercialization of products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology.

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