UCB submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of Cimzat (certolizumab pegol, CDP870) for the treatment of patients with Crohn's disease.

According to the company release, if approved, Cimzat would be the first-ever biologic utilising subcutaneous injection for the treatment of Crohn's disease.

"Our BLA submission is an important milestone for UCB. It represents the tremendous efforts of UCB's Cimzat development team, and marks UCB's entry into the biologics market," said Roch Doliveux, CEO and chairman of the executive committee for UCB.

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

The BLA includes safety and efficacy data from well-controlled clinical trials in more than 1,500 patients with Crohn's disease. The pivotal studies (PRECiSE 1 and PRECiSE 2) that support the BLA submission met their primary endpoints by demonstrating that Cimzat induced clinical response and maintained clinical response and remission in a significant percentage of patients with Crohn's disease.

The Cimzat BLA package represents the largest biologic clinical trial database and broadest, in terms of patient types, submitted to the FDA for Crohn's disease treatment.

William Sandborn, professor of medicine at the Mayo Clinic College of Medicine and a leading investigator in the Cimzat clinical trial programme said, "Our experience in the PRECiSE clinical trials programme has shown Cimzat to be a well-tolerated and effective treatment. In addition, subcutaneous administration is a welcomed attribute for patients and can offer greater convenience."

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

Cimziat is the first and only PEGylated Fab' fragment of a humanised anti-TNF alpha antibody (TNF - Tumour Necrosis factor). The engineered Fab' fragment retains the biologic potency of the original antibody. Cimziat has a high affinity for human TNF alpha, selectively neutralising the pathophysiological effects of TNF alpha.

Crohn's disease, a chronic and debilitating inflammatory disease of the gastrointestinal tract, affects nearly one million patients worldwide and an estimated 500,000 people in the United States.

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