UCB announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending
that the European Commission grants a marketing authorisation for Cimzia (certolizumab pegol), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX, has been inadequate.
In these patients, Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.
The recommendation has been granted for Cimzia to be administered as a subcutaneous injection using the pre-filled syringe. “The CHMP positive opinion is a significant milestone for UCB, but especially for people suffering from rheumatoid arthritis,” said Roch Doliveux, Chief Executive Officer of UCB.
“Cimzia can provide an additional effective treatment option for patients with this debilitating condition, helping them to lead fuller lives.”
The European Commission usually delivers a European marketing authorisation subsequent to a positive CHMP opinion within three months. Following European marketing authorisation the first launches of Cimzia, in the European Union, are anticipated before the end of 2009.
The CHMP decision is supported by data from a comprehensive clinical development programme, involving more than 2 300 patients with RA and over 4 000 patient-years experience.
In the pivotal clinical trials, reported serious adverse reactions, as with other anti-TNF’s, included infections (including tuberculosis) and malignancies (including lymphoma), and
the most commonly occurring adverse events were upper respiratory tract infections, rash and urinary tract infections. A pooled analysis of the safety data showed a low incidence of injection site pain (1.5%) and a low level of discontinuations due to adverse events (5%). Cimzia demonstrated a favorable risk-benefit profile in patients with at least up to two years of drug exposure.
On 14 May, the US Food and Drug Administration (FDA) approved Cimzia for the treatment of adult patients with moderately to severely active rheumatoid arthritis.