Belgium’s UCB says that US regulators have agreed to review its Cimzia drug for the treatment of adult patients with active rheumatoid arthritis.

The US Food and Drug Administration will look at the firm’s Biologics License Application for Cimzia (certolizumab pegol) and if approved, it would be the first and only PEGylated anti-tumor necrosis factor biologic therapy available for the treatment of RA. The BLA is based on data from more than 2,367 patients and includes three multi-centre, placebo-controlled Phase III trials.

The data from those trials showed that Cimzia, given with methotrexate, was shown to be significantly more effective than methotrexate alone for the inhibition of joint damage progression in patients with active RA as early as 24 weeks.

UCB certainly needs some good news when it comes to Cimzia as its bids to get approval of the drug as a treatment for Crohn’s disease have suffered delays. The firm was stunned by a decision by the European Medicines Agency’s Committee for Medicinal Products for Human Use in November which adopted a negative opinion on the firm’s market authorisation application and the FDA was also unimpressed with a Cimzia/Crohn’s filing and asked for additional information on the drug last March.