Cimzia(R), The Only PEGylated Anti-TNF, Recommended For Approval In The EU For Rheumatoid Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Jun 2009 - 7:00 PDT

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UCB announced 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 U.S. Food and Drug Administration (FDA) approved Cimzia® for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

Source
Cimzia
UCB