Roche (RHHBY) 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) formulation medicine.
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 medical conditions.
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 RA.
Roche currently carries a Zack Rank #1 (Strong Buy). Right now, Bayer (BAYRY) appears to be well placed with a Zacks Rank #1 (Strong Buy).