CHMP Positive on Roche's RoActemra's Subcutaneous Formulation

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Roche (RHHBY) recently received positive news when the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on the subcutaneous formulation of rheumatoid arthritis (:RA) drug RoActemra.

The CHMP recommended approval of the subcutaneous formulation of RoActemra for use both as monotherapy and in combination with methotrexate.

The positive opinion from the CHMP was based on encouraging data from two phase III studies – SUMMACTA and BREVACTA.

The data from the SUMMACTA study showed that the efficacy and tolerability of subcutaneous RoActemra was comparable with the intravenous (:IV) formulation of RoActemra.

We remind investors that RoActemra is approved in the EU for the treatment of moderate-to-severe RA who did not respond adequately or were intolerant to, previous medication with one or more disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor (:TNF) inhibitors.

RoActemra IV formulation is also approved for the treatment of active systemic juvenile idiopathic arthritis (:SJIA) and polyarticular juvenile idiopathic arthritis (:PJIA) in patients aging two years and above.

We note that RoActemra is marketed as Actemra in the U.S. The subcutaneous formulation of the drug was approved in the U.S. in Oct 2013. 

Roche has launched the subcutaneous injection formulation of Actemra in Japan in May 2013.

Sales of Actemra grew 33% in the first nine months of 2013. The subcutaneous formulation should boost sales of Actmera going forward benefiting from its increased use as a monotherapy in RA.

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

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

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