Roche is seeking approval of the drug 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).
We note that RoActemra is marketed as Actemra in the US. Actemra was approved in 2012 in the US for moderate to severe rheumatoid arthritis in adults who did not response adequately to one or more disease-modifying antirheumatic drugs (DMAR).
The CHMP’S POSITIVE opinion regarding RoActemra’s expanded usage was based on encouraging results from the phase III CHERISH study in children suffering from PJIA. Data revealed that patients treated with RoACTEMRA experienced clinically meaningful improvement in signs and symptoms of PJIA.
The positive opinion by the CHMP will be reviewed by the European Commission, which should issue a final decision in two to three months. The European Commission generally follows the recommendations of the CHMP.
Concurrent with this news, Roche also announced that the CHMP has recommended conditional approval of oncology drug Erivedge (vismodegib).
Erivedge has been recommended for treating adults with symptomatic metastatic basal cell carcinoma or locally advanced basal cell carcinoma who are not suitable for surgery or radiotherapy.
We note that a conditional marketing authorization is generally granted to a pharmaceutical product when the benefit of the same outweighs the inherent risk. Roche will require to submit additional data for full approval. It is generally granted to candidates that fulfill an unmet medical need.
We also note that Roche is developing Erivedge under a collaboration agreement with Curis, Inc (CRIS). It was approved in the US in Jan 2012 for treating patients with advanced basal cell carcinoma. Erivedge generated sales of CHF 13 million in the first quarter of 2013.
We are encouraged with the positive bout of news at Roche.
Roche currently carries a Zacks Rank #4 (Sell). Right now, stocks which look well placed, include UCB SA (UCBJY) and WuXi PharmaTech (Cayman) Inc. (WX). Both stocks carry a Zacks Rank #1 (Strong Buy).
More From Zacks.com