FDA Advisory Committee to Review REZULIN Post-Marketing Data and Supplemental New Drug Application

Business Wire, Jan 15, 1999

MORRIS PLAINS, N.J.--(BUSINESS WIRE)--Jan. 15, 1999--Following discussions with the U.S. Food and Drug Administration (FDA), Warner-Lambert (NYSE:WLA) today announced that REZULIN (troglitazone), the Company's oral therapy for type 2 diabetes, will be on the agenda at the regularly scheduled March 26th meeting of the Agency's Endocrinologic and Metabolic Drugs Advisory Committee. The Advisory Committee will review REZULIN post-marketing safety and efficacy data and Warner-Lambert's supplemental new drug application (sNDA) for combination therapy with both metformin and with sulfonylureas and metformin. The sNDA was submitted to the FDA on November 18, 1998.

Anthony H. Wild, Ph.D., president, Pharmaceutical Sector said "Warner-Lambert welcomes the opportunity for a rational review of REZULIN post-marketing safety and efficacy data in a scientific forum, particularly in light of recent media reports that have contained inaccurate claims and misstatements based on anecdotal case reports." Dr. Wild added, "we are confident that when all of the relevant scientific data are reviewed in their entirety, the Advisory Committee will agree that the benefits of REZULIN therapy for type 2 diabetes patients continue to far outweigh the risks."

Warner-Lambert has chosen to amend a 400-patient study that is designed to evaluate the potential of troglitazone in reducing insulin resistance in women with polycystic ovarian syndrome. This amendment involves the discontinuation of troglitazone treatment in the approximately 120 patients yet to complete the study. The Company will evaluate the continued therapeutic effect of troglitazone therapy in this study after treatment is stopped. In addition, Warner-Lambert will delay the initiation of a 5-year study to investigate troglitazone's effect in patients with impaired glucose tolerance, a condition of insulin resistance that precedes type 2 diabetes. Decisions about future studies involving troglitazone in these populations will be made after the Advisory Committee meeting. An ongoing 5-year trial in women with a history of gestational diabetes currently in year four will continue. It is important to note that these actions do not change the favorable benefit risk profile of REZULIN for the treatment of type 2 diabetes.

In a related matter, Warner-Lambert filed a 22-page report with the FDA in response to a citizen's petition filed by Public Citizen Health Research Group in July 1998. In its response, the Company cites specific data that support the benefits of REZULIN therapy for type 2 diabetes and offers statistics that verify an overall decline in the rate of severe liver events possibly associated with the therapy that is related to labeling revisions and increased patient monitoring. The report, which is current through November 30, 1998, cites a significant reduction in reports of liver-related deaths among patients initiating therapy in 1998. Warner-Lambert concluded in the report that, by all objective measures, liver enzyme monitoring has helped to reduce the already rare risk of serious liver events.

While Warner-Lambert cannot exclude the possibility of future serious adverse events, the Company believes that, with proper monitoring and patient awareness, health care professionals can keep these rare but serious adverse events to an absolute minimum. It is important to note that fatal adverse events have been reported in connection with most, if not all, oral anti-diabetic agents.

Warner-Lambert has also developed a special informational package insert (patient package insert) for patients, currently under review by the FDA, that outlines the signs and symptoms of liver abnormalities and the liver enzyme monitoring requirements. The Company anticipates continuing discussions with the FDA regarding REZULIN between now and the date of the Advisory Committee meeting.

Warner-Lambert is a global company devoted to discovering, developing, manufacturing and marketing quality pharmaceutical, consumer health care, and confectionary products. It employs more than 40,000 people worldwide.