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Label Expansion for Roche's RoActemra

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Roche (RHHBY) recently announced that it obtained European Medicines Agency (:EMA) approval for the label expansion of its rheumatoid arthritis (:RA) drug RoActemra.

RoActemra is now approved for the treatment of polyarticular juvenile idiopathic arthritis (:PJIA) in patients (aged two years or more) who have responded inadequately to previous treatment with methotrexate (MTX).

The EMA approved the use of the drug as a monotherapy or in combination with MTX.

Approval was expected as Roche had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Apr 2013 for the PJIA indication.

The EMA approval was based on encouraging results from the phase III CHERISH study in children suffering from PJIA. Data from the study revealed that patients treated with RoActemra experienced clinically meaningful improvement in signs and symptoms of PJIA.

We note that RoActemra is marketed as Actemra in the US. In Apr 2013, the US Food and Drug Administration (:FDA) approved Actemra for the treatment of PJIA.

Actemra was approved in 2012 in the US for moderate-to-severe RA in adults, who did not respond adequately to one or more disease-modifying antirheumatic drugs (DMAR).

Actemra was also approved in the US and EU in Apr 2011 and Aug 2011, respectively, for the treatment of patients (aged two and above) suffering from active systemic juvenile idiopathic arthritis (sJIA).

We are encouraged with Roche’s efforts to expand Actemra’s label. In May 2013, Roche launched the subcutaneous injection formulation of Actemra in Japan and the subcutaneous version of the drug is currently under review in the US and the EU.

The intravenous version of Actemra is available in Japan since Jun 2005 and Actemra is also approved in Japan for PJIA and sJIA.

However, competition is stiff in the RA market given the presence of treatments like UCB’s (UCBJY) Cimzia and AbbVie Inc.’s (ABBV) Humira among others.

Roche currently carries a Zack Rank #3 (Hold). Right now, Santarus, Inc. (SNTS) appears to be well placed with a Zacks Rank #1 (Strong Buy).

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