New Anti-Obesity Medicine
The need for chronically administered safe drug treatment, the FDA's commitment to support new drug development efforts, and the growing global market for anti-obesity drugs has fueled a surge in development of new anti-obesity drugs in the biotech and pharma industries.
Part of the mandate for the FDA's Obesity Working Group, established in 2003, is to "make recommendations on ways to encourage development of new or enhanced therapeutics." This mandate includes revision of the 1996 guidelines intended to help drug makers develop new obesity products in a climate of great clarity and an improved review process.
"The FDA agrees that obesity presents great problems both in the U.S. and elsewhere in the world," comments David Orloff, M.D., director of the FDA's division of metabolic and endocrine drug products.
"We are fully supportive of the development of drugs to treat obesity and have been for years." However, he cautions, "At present, while there are many interesting possibilities for new drugs, it is important to understand that there are no miracles on the horizon and management of obesity and disease prevention requires not only the judicious use of therapeutics but lifestyle changes in order to be successful."
A greater knowledge base now exists about the neuroendocrine pathways, hormones and/or neurotransmitters that impact appetite, fat storage, and metabolic rate. Drug developers are taking advantage of new drug targets to attack fat on a variety of fronts, with 200 novel drugs in development worldwide.
Some targets for new drugs include hunger and satieity-signalling gastronintestinal peptides and/or their receptors, like ghrelin and Peptide Y (PYY), Glucagon-like peptide 1 (GLP-1), and colecystokinin (CCK). Other targets include CNS targets, like the hypothalamus and brain stem, involved in hunger and satiety feedback control mechanisms.
The U.S. market alone for anti-obesity drugs is about $550 million, and Americans spend more than $33 billion annually on weight loss products and services.
The emphasis on preventive healthcare and health maintenance by third-party healthcare payers favors a reimbursement climate in which weight-management drugs can potentially prosper.
And, there's a lot of room for more than one novel obesity drug. According to obesity experts, it's likely that multiple drugs will be required. Arthur Frank, M.D., medical director of the George Washington University obesity program, says that because of rapid accumulation of more sophisticated knowledge about regulatory mechanisms impacting food intake, "Everything we are doing now will be obsolete in 10 years.
"I am reasonably convinced that physiological eating control mechanisms have so many compensatory factors that no single medicine will be sufficient and medicines in combination will be needed for successful management."