) recently announced that the company received a positive opinion
for rheumatoid arthritis drug RoACTEMRA (tocilizumab) from the
Committee for Medicinal Products for Human Use (CHMP).
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 (DMARD).
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
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
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
). 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
WuXi PharmaTech (Cayman) Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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