UCB submits Biologics License Application to FDA for new treatment in Crohn's disease

By E. Janene Geiss

Philadelphia, March 2 - UCB announced Thursday the submission of a Biologics License Application to the Food and Drug Administration for the approval of Cimzia (certolizumab pegol, CDP870) for the treatment of patients with Crohn's disease.

If approved, Cimzia would be the first biologic using subcutaneous injection for the treatment of Crohn's disease, according to company news release.

"Our BLA submission is an important milestone for UCB; it represents the tremendous efforts of UCB's Cimzia development team and marks UCB's entry into the biologics market," Roch Doliveux, chief executive officer and chairman of the executive committee for UCB, said in the release.

"We plan to request marketing authorization from the European Agency for the Evaluation of Medicinal Products in a matter of weeks. UCB is also continuing its research and development work to explore additional auto-immune diseases for this promising biologic," Doliveux added.

The application includes safety and efficacy data from well-controlled clinical trials in more than 1,500 patients with Crohn's disease. The pivotal studies that support the submission met their primary endpoints by demonstrating that Cimzia induced clinical response and maintained clinical response and remission in a significant percentage of patients with Crohn's disease, officials said.

Cimzia said its application represents the largest biologic clinical trial database and broadest, in terms of patient types, submitted to the FDA for Crohn's disease treatment.

In addition to the completed and ongoing studies in Crohn's disease, Cimzia studies also are ongoing in the treatment of rheumatoid arthritis and psoriasis.

Crohn's disease, a chronic and debilitating inflammatory disease of the gastrointestinal tract, affects nearly 1 million patients worldwide and affects an estimated 500,000 people in the United States. People with Crohn's disease may suffer an ongoing cycle of "flare-up" and remission. Symptoms vary among people but include persistent diarrhea, abdominal pain, and loss of appetite/weight, fever or rectal bleeding.

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

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