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Drug Development
Regulatory submissions made for Humira for rheumatoid arthritis
February 20th, 2005
Abbott (ABT) announced it has simultaneously submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market Humira (adalimumab) for the treatment of early rheumatoid arthritis (RA). Currently, Humira is indicated for the treatment of patients with moderately to severely active RA who have had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs). The submission is based on results of the 2-year, phase III PREMIER Study, which found that patients with early RA (RA of less than 3 years'...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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