) received encouraging news when the U.S. Food and Drug
Administration (FDA) approved a subcutaneous (SC) formulation of
its rheumatoid arthritis (RA) drug Actemra.
Actemra is approved for the treatment of adults with
moderately to severely active RA who have used one or more
disease-modifying antirheumatic drugs (DMARDs). Actemra was
originally approved by the FDA in 2010 as an intravenous (IV)
The approval for subcutaneous formulation is based on positive
data from the phase III trials, SUMMACTA and BREVACTA. In the
randomized double blind SUMMACTA trial (n=1,262), the SC
formulation of Actemra 162 mg given weekly plus DMARDs was more
effective than 8 mg/kg of Actemra given intravenously.
Meanwhile, results from the randomized, double-blind BREVACTA
study showed that RA patients, who received the SC formulation of
Actemra every two weeks plus DMARDs, were significantly more
likely to have achieved a 20% reduction in tender and swollen
joint counts in addition to a corresponding improvement in other
We remind investors that 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
However, competition is stiff in the RA market given the
presence of treatments like
) Cimzia and
) Humira, among others.
Roche currently carries a Zack Rank #1 (Strong Buy). Right
) appears to be well placed with a Zacks Rank #1 (Strong
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