FDA Backs Approval of Abbott Laboratories's Humira for New Use

Published: Aug 30, 2012

The benefits of using Abbott Laboratories (ABT)’ rheumatoid arthritis drug Humira for patients with a type of ulcerative colitis outweigh the risks, a U.S. advisory panel said. Advisers to the Food and Drug Administration voted 15-2 today in support of Humira’s use in those with moderate to severe ulcerative colitis who don’t respond to conventional therapies. They also voted that the Abbott Park, Illinois-based company doesn’t need to conduct more drug studies in advance of approval. The FDA isn’t required to follow the recommendations. Abbott is seeking to expand the use of Humira, the company’s top-selling product, in six illnesses, including ulcerative colitis and pediatric Crohn’s disease. Together, the new indications would contribute about $1 billion in sales, said Elizabeth Hoff, a company spokeswoman. Abbott still must find the best dose for colitis patients, panel members said.

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