UCB receives CHMP positive opinion for Cimzia

UCB has announced that the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending extending the European Union marketing authorization for the use of Cimzia® (certolizumab pegol) in the treatment of adult patients with severe active axial spondyloarthritis (axSpA).

AxSpA is a form of spondyloarthritis that affects mainly the spine and sacroiliac joints, and comprises both ankylosing spondylitis (AS) and axSpA without X ray evidence of AS (non-radiographic axSpA [nr-axSpA]) sub-groups.[1] An approval for adult patients living with severe active axial spondyloarthritis would represent the second indication for Cimzia in countries of the European Union. In general, the European Commission follows the recommendations of the CHMP and usually delivers its final decision within two months of the CHMP recommendation.  http://fortalent.com/blog/view/s/2014-02-03-tips-for-disposing-of-grease-from-your-face/

"The CHMP positive opinion is an important milestone since people living with severe active axSpA in Europe may soon have a new treatment option whether or not they have X ray evidence of structural damage to their sacroiliac joints," said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB.

 "This is particularly important for patients living with axial spondyloarthritis without radiographic evidence of AS, whose symptoms may be just as debilitating as those with AS but for whom treatment options are currently limited."

The positive opinion for severe active axSpA comprising AS and axSpA without radiographic evidence of AS follows the EMA's review of data from the RAPID™-axSpA study which was the first randomized, controlled, Phase 3 study of an anti-TNF to enroll both AS and axSpA without radiographic evidence of AS patients.2 The study is an on-going, Phase 3, multicenter, randomized, double-blind, placebo-controlled trial that was designed to evaluate the efficacy and safety of certolizumab pegol in patients with active axSpA.[3] The primary endpoint of the RAPIDT™-axSpA study was ASAS20 at week 12, and was achieved with clinical and statistically significant improvements in ASAS20 responses in both dosing arms (200 mg every 2 weeks and 400 mg every 4 weeks) vs. placebo (p≤0.004).[2] The safety profile for axial spondyloarthritis patients treated with certolizumab pegol was consistent with the safety profile of certolizumab pegol reported in rheumatoid arthritis trials.[2]

In the European Union, certolizumab pegol is approved in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs, including MTX. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.[4]

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The EMA is currently reviewing another filing for certolizumab pegol in the treatment of adult patients with active psoriatic arthritis. In the US, both PsA and axSpA filings are currently under review by the US Food and Drug Administration (FDA).
About RAPID™-axSpA study[3]

The RAPID™-axSpA study is an ongoing Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of certolizumab pegol in patients with active axSpA. Patients (n=325) were randomized 1:1:1 to placebo, or 400 mg certolizumab pegol at week 0, 2 and 4 loading dose followed by either 200 mg certolizumab pegol every two weeks or 400 mg certolizumab pegol every four weeks. Patients enrolled in the study must have active disease and failed at least one non-steroidal anti-inflammatory drug (NSAID). Within the placebo arm, patients who failed to achieve an ASAS20 response at weeks 14 and 16 were re-randomized at week 16 to receive certolizumab pegol 200 mg every 2 weeks or 400 mg every 4 weeks, following the loading dose.