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news.To treat moderate to severe active RA in adult patients
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The European Commission (EC) has approved UCB’s Cimzia, in combination with MTX, for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX.
Reportedly, Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
The company commenting on the approval of Cimzia said that it has been approved to be administered as a subcutaneous injection using the new prefilled syringe designed in partnership with OXO Good Grips.
In the RAPID 1 and RAPID 2 clinical trials statistically significant ACR20 and ACR50 responses were achieved from week 1 and week 2, respectively, in both clinical trials compared to placebo. Responses were maintained through weeks 52 (RAPID 1) and 24 (RAPID 2), the company said.
Additionally, the RAPID 1 open label extension study, in patients who responded to treatment with Cimzia, showed that the improvements gained in ACR20/50/70 scores were sustained for two years in patients receiving Cimzia, in combination with MTX.
Radiographic data showed inhibition of the progression of structural joint damage, was observed at 24 weeks of treatment, in RA patients treated with Cimzia in combination with MTX and sustained for 100 weeks (100 week data are results from the open-label extension study of RAPID 1).
The recommended starting dose of Cimzia for adult patients with RA is 400mg (as 2 injections of 200mg each on one day) at weeks 0, 2 and 4, followed by a maintenance dose of 200mg every 2 weeks. MTX should be continued during treatment with Cimzia where appropriate.
The European approval 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.
The FDA has recently approved Cimzia, together with MTX, for the treatment of adult patients with moderately to severely active RA.
Iris Loew-Friedrich, chief medical officer of UCB, said: “Cimzia has been shown to rapidly reduce the rate of progression of joint damage and to improve measurements of patients’ physical function. These are areas of a key concern for rheumatologists when treating patients with active RA, and we therefore believe Cimzia provides an important new treatment option.”