AbbVie’s (ABBV) Humira Gains Yet Another FDA Approval

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AbbVie’s (ABBV) key growth engine is Humira. Sales of the company’s flagship product, approved for multiple indications, had increased 10.7% to $10.7 billion in 2013. The company expects Humira to continue exhibiting double-digit operational growth.

Last week, AbbVie secured yet another FDA approval for Humira. Humira is now cleared in as many as eight indications in the U.S. Following the latest approval, AbbVie can be used to treat children (aged six years and above) suffering from moderately to severely active Crohn's disease, an inflammatory bowel disease. Humira therapy can also be used to achieve and maintain clinical remission in the above mentioned patient population. The patients did not respond favorably to corticosteroids or immunomodulators including azathioprine, 6-mercaptopurine or methotrexate. The latest label expansion for Humira was gained on the basis of encouraging data from a phase III multi-center, randomized, double-blind study (IMAgINE-1).

AbbVie stated in its press release that following the FDA’s decision, Humira becomes the first and only approved biologic therapy that can be administered at home in the above patient population. AbbVie also said that the disease, characterized by disorders including abdominal pain, weight-loss and diarrhea, is prevalent in approximately 38,000 children and teenagers in the U.S. The latest label expansion will further boost the sales potential of AbbVie’s flagship product.

Investors interested in the health care space may consider stocks like Gilead Sciences (GILD), Medivation (MDVN) and Endo International (ENDP).

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