Chugai Pharmaceutical Company, Limited – a subsidiary of Roche (RHHBY) – 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 the EU.
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 (sJIA).
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 UCB’s (UCBJF) Cimzia and AbbVie Inc.’s (ABBV) Humira in the RA space.
Roche, a large cap pharma company, carries a Zacks Rank #4 (Sell), reflecting short-term pressure on the stock. Novo Nordisk (NVO) appears to be favorably placed in the large cap pharma space, carrying a Zacks Rank #2 (Buy).
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