UCB - Cimzia: that's a "no" then?

Belgian drugmaker UCB suffered a major blow last week after European advisors upheld a negative opinion on Cimzia for Crohn’s disease, just days after the firm announced it was temporarily recalling its Parkinson’s disease patch Neupro.

The decision follows an appeal by UCB after the European Medicines Agency’s Committee for Medicinal Products for Human Use originally advised turning down its application to market Cimzia (certolizumab pegol) - the first and only PEGylated anti-tumour necrosis factor alpha drug - for Crohn’s back in November last year. According to the CHMP, although certain issues had been resolved during the appeal process, including fears over a possible increased risk of bleeding associated with the product’s use, it remains concerned over the drug’s general safety and effectiveness profile, and so concluded that its benefits to patients do not outweigh the potential risks in this setting.

But UCB will likely be feeling particularly disappointed with the decision, given that it recently released six-week data from a 539-patient Phase IIIb trial showing that the drug is effective in treating patients with the disease who are intolerant or no longer responding to infliximab. At week six of the 26-week trial, 61% of patients receiving subcutaneous injections of Cimzia 400mg at weeks zero, two and four had achieved the primary endpoint of a decrease in Crohn's disease, with 39% in remission.

The second rejection by the Committee certainly represents a major setback to the firm as Cimzia, which is approved for use in Switzerland, has been touted as a blockbuster that could help plug the gap in sales resulting from the loss of patent protection on its biggest earners – the allergy drug Zyrtec (cetirizine) and the antiepileptic Keppra (levetiracetam) – in 2007 and 2009, respectively.
Source: PharmaTimes