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Abbott
Positive opinion granted for Humira in Europe for rheumatoid arthritis
August 10th, 2005
Abbott announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a positive opinion recommending approval of Humira (adalimumab) for the first-line treatment of moderate to severe early rheumatoid arthritis (RA). The positive opinion is based on results of the 2-year, phase III PREMIER study that found that methotrexate-naive patients with early RA, defined as RA for less than 3 years, experienced significant improvement in signs and symptoms while taking Humira in combination with methotrexate. The PREMIER study also found that approximately one in two...
Source: Biotech Week (2005-08-10)
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