PRINCETON, NJ (December 23, 2004) – Bristol-Myers Squibb Co. has submitted a New Drug Application to the United States Food & Drug Administration (FDA) for muraglitazar, an investigational agent under development for the treatment of patients with type 2 diabetes. Bristol-Myers Squibb and Merck & Co., Inc. are collaborators in the global development and commercialization of muraglitazar.
Muraglitazar, discovered by Bristol-Myers Squibb, has the potential to be the first in a novel class of drugs known as dual peroxisome proliferators activated receptor agonists to be approved for marketing in the U.S., the company said.
The company also provided an update on the rolling submission of the Biologics License Application 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, the company said.
Complete non-clinical and clinical sections of the Biologics License Application have 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, the company said.
Bristol-Myers Squibb is a global pharmaceutical and related health careproducts company.