Chugai Pharmaceutical Company, Limited - a subsidiary of
) - announced that the subcutaneous injectable version of its
rheumatoid arthritis (RA) drug Actemra (tocilizumab) has been
approved by the Japanese health authorities. The subcutaneous
version of the drug has been approved for treating RA patients
who have not responded adequately to one or more existing
medications for the disease.
We note that a phase III study, conducted in Japan,
demonstrated that the subcutaneous version of Actemra was as
effective as its intravenous formulation. Moreover, the safety
profiles of both versions were comparable. The subcutaneous
version of the RA drug is currently under review in the US and
We remind investors that the intravenous version of Actemra is
available in Japan since Jun 2005. Subsequently, the drug was
cleared for additional RA indications (including prevention of
structural damage of joints), polyarticular-course juvenile
idiopathic arthritis and systemic juvenile idiopathic arthritis
We note that the intravenous version of the drug is available
in the EU (brand name: RoActemra) since 2009 for treating adult
RA patients who have either responded insufficiently to, or were
intolerant to, previous medication with one or more
disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis
factor (TNF) inhibitors.
Actemra was approved by the US Food and Drug Administration
(FDA) in Jan 2010 for treating adults suffering from moderately
to severely active RA who have responded inadequately to one or
more TNF inhibitors. The indication was expanded in Oct 2012.
The intravenous version is currently approved in more than 100
countries including the US, EU, India, Brazil, Switzerland and
Australia. The RA market is highly competitive. Actemra primarily
faces competition from
) Cimzia and
) Humira in the RA space.
Roche, a large cap pharma company, carries a Zacks Rank #4
(Sell), reflecting short-term pressure on the stock.
) appears to be favorably placed in the large cap pharma space,
carrying a Zacks Rank #2 (Buy).
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