Off-Label Use of Diabetes Drug for Weight Loss: Anecdotes to RWE
(Thursday, October 20, 2022)
A diabetes drug with a side-effect of weight loss has become popular for its off-label use as a weight-loss drug presenting a classic test case where medical experience could have potential applications for RWE-driven new indications. The drugs of the class GLP-1 RA (Glucagon-Like Peptide 1 Receptor Agonist) are approved for the management of Type 2 diabetes and lead to weight loss, making then attractive for people looking for cosmetic weight loss. The most popular drug of this class is semaglutide that is sold under two brand names, Ozempic and Wegovy, both manufactured by Novo Nordisk and approved only as diabetes drugs that can be prescribed for weight management in extremely obese patients. However, many clinical reports indicate that semaglutide can reduce weight for everyone, leading to its popularity for off-label use as a weight-loss drug. The only apparent difference between Ozempic and Wegovy is the price tag; Ozempic costs about $900 while Wegovy costs about $1350 for a month’s supply, before insurance. Patients looking for moderate to minor weight-loss have been asking their doctors to write off-label prescriptions at such a high rate that both drugs are currently in short supply. Apart from the interesting medical story of a popular off-label legal use, this story presents an excellent example of Real World Data (RWD) leading to Real World Evidence (RWE) based on off-label use captured in medical records. Semaglutide is intended for chronic use; stopping the drug reverses the benefits. Also, the risks of adverse events with the chronic drug use are balanced for patients with Type-2 diabetes who suffer from diabetes related adverse effects and advanced obesity. However, for people who are take it only for moderate weight loss and are otherwise healthy, the side effects such as gastrointestinal issues and pancreatitis become a greater concern. It is critical that the effects of drugs for moderate weight loss be studied so patients can be prescribed the drug properly. The best way to collect such data without waiting for long-term clinical trials is mining their medical records to harvest RWE for important use and experience information from patients which can be used for label revisions and new indication (mild to moderate weight loss, or weight management). This could help create new formulations that are easier to administer than the injectable versions currently popular. Perhaps Novo Nordisk and Eli Lilly, the manufacturers of semaglutide products, are already doing this work.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC