Pfizer Inc. (PFE) recently announced that its rheumatoid arthritis treatment, Xeljanz, gained approval in Japan. The Japanese Ministry of Health, Labor and Welfare (:MHLW) approved Xeljanz for the treatment of rheumatoid arthritis in adults who have not responded adequately to existing therapies.
Xeljanz can be used in patients in whom clinical symptoms related to the disease remain even after the patients have undergone treatment with at least one other disease-modifying antirheumatic drug (DMAR), such as methotrexate.
Pfizer said that Xeljanz will be commercially launched once the National Health Insurance listing is completed. Pfizer will be promoting the product with Takeda Pharmaceutical (TKPYY) in Japan. Pfizer also co-promotes Enbrel in Japan with Takeda.
We note that Xeljanz gained approval in the US in early Nov 2012. Xeljanz is the first oral treatment to gain approval in a new class of medicines known as Janus kinase (:JAK) inhibitors. The product represents a new treatment option for patients who respond inadequately to or are unable to tolerate methotrexate.
Pfizer currently carries a Zacks Rank #3 (Hold). Pfizer’s 2013 guidance was in-line with expectations. While near-term earnings will be driven by cost cutting efforts and share repurchases, longer-term growth will depend on the success of drug development. The company’s pipeline needs to deliver given the Lipitor loss of exclusivity and the upcoming loss of exclusivity on additional products in the next few years.
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