Belgian drug firm UCB has suffered a major blow after European advisers upheld a negative opinion on Cimzia® (certolizumab pegol) for Crohn’s disease.
The decision follows an appeal by UCB after the EMEA’s Committee for Medicinal Products for Human Use (CHMP) advised turning down its application to market Cimzia – the first and only PEGylated anti-tumour necrosis factor alpha drug – for Crohn’s in November last year.
The CHMP said certain issues had been resolved during the appeal process, including fears over a possible increased risk of bleeding associated with the product’s use, but the committee remained concerned over the drug’s general safety and effectiveness profile, so concluded that the benefits to patients did not outweigh the potential risks in this setting.
UCB will probably be feeling particularly disappointed over the decision, given that it recently released six-week data from a 539-patient phase IIIb trial demonstrating the drug’s effectiveness in treating patients with the disease who were 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.
UCB senior vice-president Olav Hellebo said: “The CHMP’s negative opinion is disappointing for UCB. Nevertheless, we are pleased that specific safety and quality concerns raised by the committee in November were resolved through the appeal process.
“UCB remains committed to the development of medicines to satisfy the needs of patients with autoimmune disorders.”
The second CHMP rejection 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 UCB’s biggest earners – the allergy drug Zyrtec® (cetirizine) and the antiepileptic Keppra® (levetiracetam) – in 2007 and 2009, respectively.