UCB (UCBJY) and Astellas Pharma Inc. (ALPMY) recently announced the launch of Cimzia (certolizumab pegol) in Japan for the treatment of adult patients with rheumatoid arthritis (:RA), who have not responded adequately to conventional treatment. In Dec 2012, Cimzia had received Japanese marketing approval.
In Jan 2012, UCB and Astellas had entered into an agreement to develop and commercialize Cimzia, for RA, in Japan. Astellas will make a milestone payment to UCB on the launch of the product.
As per the agreement, UCB will manufacture and supply Cimzia and Astellas will look after distribution and sales. Together, the companies will look after marketing activities in Japan.
Data from studies showed that adult patients showed improvements in the signs and symptoms of RA after one week after receiving Cimzia with or without methotrexate (MTX).
The safety profile of Cimzia for RA in Japanese trials was in line with the safety profile reported in earlier studies outside Japan.
UCB is looking to get Cimzia approved for the treatment of adults with active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA). UCB’s regulatory filings with the US Food and Drug Administration (:FDA) and the European Medicines Agency (:EMA) were based on the phase III RAPID-PsA and RAPID-axSpA studies.
We note that UCB’s Cimzia is currently approved in the US for the treatment of moderate-to-severe rheumatoid arthritis patients above 18 years and for reducing the signs and symptoms of Crohn’s disease (:CD) and maintaining clinical response in moderate-to-severe CD patients above 18 years, who have failed prior therapy.
Cimzia is also approved in the EU in combination with MTX for the treatment of moderate-to-severe active rheumatoid arthritis in adults who have responded inadequately to disease-modifying antirheumatic drugs (DMARDs), including MTX. In case of intolerance to MTX or inappropriateness with MTX, Cimzia can be given as monotherapy.
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