Lilly receives approvable letter for use of Prozac in treating bulimia, announces voluntary withdrawal of Lovan application

Business Wire, Nov 10, 1994

INDIANAPOLIS--(HealthWire)--Nov. 10, 1994--Eli Lilly and Company announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) in support of the use of Prozac(R) for the treatment of bulimia.

The issuing of an approvable letter is generally the agency's final step before granting a company permission to market a new product or to market an existing product for a new use. Lilly will work with the FDA to obtain final approval for this indication.

``Bulimia is a serious medical condition that can have devastating effects on its victims and their families,'' said Gary D. Tollefson, M.D., Ph.D., Lilly executive director of clinical investigation and regulatory affairs for psychopharmacology. ``The FDA's approvable letter is an indication of the agency's confidence in Prozac as a safe and effective treatment for those who suffer from this disease.''

Bulimia is an eating disorder that afflicts more than 1 million Americans per year. Patients with this chronic, relapsing illness suffer from a variety of symptoms, such as uncontrolled binge-eating, feelings of lack of control, and self-induced vomiting. Other psychiatric illnesses, such as depression and obsessive-compulsive disorder (OCD), occur in a substantial number of patients with bulimia, Tollefson said.

Prozac, the world's largest selling antidepressant, was approved in the United States for the treatment of clinical depression in 1987 and for OCD in March 1994. It is the only product that may be marketed in the United States for both depression and OCD.

To date, Prozac has been approved for use in the treatment of depression in more than 75 countries, for OCD in 16 countries, and for bulimia in 19 countries.

Withdrawal of Lovan submission

Lilly also announced today that it has voluntarily withdrawn its New Drug Application (NDA) to the FDA for Lovan(TM) as a treatment for obesity.

The decision was made following the FDA's recent proposal of new criteria for approval of obesity treatments. Data in the company's submission for Lovan were based on six-month efficacy studies, which were the criteria the FDA had in place at the time of the filing. New draft guidelines proposed by the FDA require that all NDAs for obesity treatments contain 24-month efficacy studies.

The agency's proposed new guidelines will be discussed at an FDA Advisory Committee hearing on obesity in 1995. At that hearing, the North American Association for the Study of Obesity, an independent research organization, is expected to present its own suggested guidelines for evaluating obesity medications. Based on the outcome of these discussions, Lilly will consider whether or not to resubmit its Lovan application to the FDA or to develop and refile additional data and analyses in support of Lovan.

Pending formal adoption of new guidelines by the FDA, Lilly has decided that the additional investment required to complete the 24-month studies is not in the best strategic interest of shareholders at this time, given the multiple new product opportunities in the Lilly pipeline.

``We are fortunate to have one of the most promising product pipelines in the pharmaceutical industry,'' said August M. Watanabe, M.D., a vice president of the company and president of Lilly Research Laboratories. ``Lilly has several compounds in late-stage clinical development that are targeted for cancer, osteoporosis, schizophrenia, diabetes, and other devastating diseases. Based upon the substantial investment required to conduct Phase III clinical trials--the most comprehensive and costly stage of clinical development--we decided to focus our research efforts on these other opportunities at this time.''

Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Indiana, that is working with its customers worldwide to help ensure that diseases are prevented, managed, and cured with maximum benefit and minimum cost to patients and society.

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Lovan(TM) (fluoxetine hydrochloride) Prozac(R) (fluoxetine hydrochloride, Dista)

CONTACT: Eli Lilly and Company, Indianapolis

Edward A West, 317/276-3655