Roche receives EU recommendation for RoActemra extension

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Roche receives EU recommendation for RoActemra extension

http://www.zenopa.com/news/800554221/Roche_receives_EU_recommendation_for_RoActe\

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Posted on 24/05/2011 in Pharmaceutical Company Product News

Roche has received a recommendation for European approval of a new

application extension for its rheumatoid arthritis drug RoActemra.

The European Medicines Agency's Committee for Medicinal Products for Human

Use has backed the company's efforts to seek approval for the drug as a

treatment for active systemic juvenile idiopathic arthritis (sJIA) in

patients aged two and above.

Roche hopes to gain ratification for RoActemra in this specification on its

own or in combination with methotrexate among those who have failed to

respond to previous therapy with NSAIDs and systemic corticosteroids.

The authorisation application was based on positive data from Tender, a

phase III trial that demonstrated the safety and efficacy of RoActemra as an

sJIA treatment compared to placebo.

A final decision on approval will be taken by the European Commission in

July 2011.

Earlier this month, Roche submitted authorisation applications in both the

EU and US for vemurafenib, a new treatment option for certain forms of

metastatic melanoma.