Orencia
Generic name: abatacept
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Graft Versus Host Disease - Prophylaxis
Bristol-Myers Squibb Provides Regulatory Update for Abatacept
PRINCETON, N.J., December 23, 2004 -- Bristol-Myers Squibb Company today announced that the company has provided an update on the rolling submission of the Biologics License Application (BLA) for abatacept submitted under the provisions of FDA's Continuous Marketing Application, Pilot 1.
Abatacept is an investigational biologic drug for the treatment of rheumatoid arthritis and its development program was granted Fast Track status by the FDA. Complete Non-Clinical and Clinical sections of the BLA have already been submitted to the FDA and the remaining sections will be submitted in early 2005.
Abatacept is Bristol-Myers Squibb's first internally discovered biologic and, if approved, would be the first in a new class of agents called selective T-cell co-stimulation modulators.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
For further information, please visit www.bms.com
Posted: December 2004
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Orencia (abatacept) FDA Approval History
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