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Home Industry News UCB asked for new Cimzia safety update

UCB asked for new Cimzia safety update

6th January 2009

UCB has been asked to provide a new safety update relating to its biologics license application (BLA) for Cimzia (certolizumab pegol) as a treatment of rheumatoid arthritis (RA).

The company, which originally received approval for Cimzia as an option for Crohn’s disease sufferers in April last year, said it has also been requested to give the Food and Drug Administration all clinical data collected since the BLA was filed in February 2008.

This followed a clinical programme UCB undertook involving over 2,300 patients in various multicentre placebo-controlled trials.

It added that all possible efforts will be applied “diligently” to help process the request and see the pegylated anti-TNF drug approved for RA.

“UCB is confident and committed to making Cimzia available to people living with moderate to severe rheumatoid arthritis and other inflammatory conditions as soon as possible,” added the organisation’s chief medical officer Dr Iris Loew-Friedrich.

Reuters responded to the news early this morning, reporting a drop of six per cent in the company’s shares since the Cimzia request.

Morgan Stanley told the news provider that a final decision on the drug could be revealed in the second half of 2009 dependent on UCB’s timeliness with its response.

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