Roche (RHHBY - Free Report) 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.
However, competition is stiff in the RA market given the presence of treatments like UCB’s (UCBJF - Free Report) Cimzia and AbbVie Inc.’s (ABBV - Free Report) Humira, among others.
Roche currently carries a Zack Rank #1 (Strong Buy). Right now, Bayer (BAYRY - Free Report) appears to be well placed with a Zacks Rank #1 (Strong Buy).