Good news for obese Americans: FDA considers allowing a combination version of Eli Lilly's weight-loss drug

According to the Zhitong Finance APP, the U.S. Food and Drug Administration (FDA) has agreed to reconsider its decision made last month to ban private drug compounders from selling their own compounded versions of Eli Lilly (LLY.US) weight loss and diabetes treatment drugs. In a court filing, the agency stated that it is now considering allowing compounding pharmacies and drug facilities to continue providing the relevant drugs, while also indicating a review of whether their active ingredients are in short supply. For the obese and diabetic population, the compounded versions of Eli Lilly's drugs, which combine weight loss and blood sugar lowering functions, are cheaper than the official branded versions of Eli Lilly. This latest decision is in response to a lawsuit filed by the compounding industry organization, the Outsourcing Facilities Association, on Monday. Following the FDA's decision to reconsider on Friday, Judge Mark Pittman in the Fort Worth, Texas area suspended the lawsuit. The FDA's previous decision on September 30 jeopardized the ability of compounding pharmacies to sell Zepbound, known as the "miracle weight loss drug" under Lilly, and Mounjaro, a drug with both weight loss and diabetes treatment functions. The FDA's decision at that time meant removing the active ingredient tirzepatide of these highly demanded weight loss drugs from the "shortage drug list". These decisions by the FDA are seen as a response to the lawsuit filed by the Outsourcing Facilities Association. Following the FDA's decision to reconsider on Friday, Judge Mark Pittman in Fort Worth, Texas, suspended the lawsuit. The FDA's previous decision would have cut off access to compounded formulations that many obese patients relied on during the shortage of Lilly's official weight loss drugs. These compounded versions prepared by pharmacies are much cheaper than the official price of Lilly's branded weight loss drugs. While some insurance companies typically provide insurance for diabetes drugs like Lilly's tirzepatide, many insurance companies do not cover weight loss drugs. Lee Rosbush, Chairman of the Outsourcing Facilities Association, stated in a recent statement that the association is "very pleased for our members and the many patients they serve, as the FDA has agreed to reconsider its previous decision". The shortage of Eli Lilly's weight loss drugs, competing with Danish competitors such as Novo Nordisk's Ozempic, has stimulated demand for compounded formulations. Since the end of 2022, Mounjaro, one of Lilly's weight loss drugs, has been on the FDA's shortage drug list, while Zepbound was added to the list in April. Unlike traditional branded or generic drugs, compounding pharmacies can sell their own compounded versions of Eli Lilly's weight loss drugs without FDA approval. Compounding pharmacies that deal with compounded drugs may prepare customized drugs for specific patients to fill prescriptions, while so-called "outsourcing facilities" mass-produce the compounded drugs needed by these pharmacies FDA's reconsideration is due to the fact that US federal regulations allow pharmacies to sell compounded versions of FDA-approved drugs to meet demand in the event of drug shortages. If a drug is not in severe shortage, its compounded version cannot be produced regularly or in large quantities. The Outsourcing Facilities Association emphasized in its lawsuit that the actual supply situation is still in shortage, but the FDA removed the core component tirzepatide of Lilly's weight loss drug from the FDA's shortage list. As early as August, Lilly began sending cease-and-desist orders to remote medical companies, health centers, and medical spas selling the compounded versions Zepbound and Mounjar. Lilly's management also emphasized that lawsuits will be filed against sellers making false claims about selling FDA-approved weight loss drug compounded versions in the future. The active ingredient in Novo Nordisk's weight loss drug, semaglutide, is still on the FDA's drug shortage list. Whether it is the official brand weight loss drug from Lilly or the compounded drug, the key active ingredient, tirzepatide, is the same, so theoretically their biological effects should be similar. The main difference is that the excipients in Lilly's branded drugs (such as solvents, preservatives, etc.) are optimally designed to ensure the stability of the drug during transportation and storage, and extend the drug's shelf life. The excipients and other additives used in compounded drugs may be different, which could affect the drug's absorption, metabolism rate, and efficacy. Some compounded drugs may have shortcomings in drug stability, especially drugs sensitive to external factors such as temperature and light. A recent study found that obese patients using Lilly's Mounjaro, a weight loss and diabetes treatment drug (core component tirzepatide), had significantly more weight loss compared to patients using Novo Nordisk's Ozempic, a weight loss and diabetes treatment drug (core component semaglutide). This study is significant for the "Novo-Lilly" two pharmaceutical giants dominating the weight loss drug market, and may lead more obese patients or those trying to lose weight through injections to switch to Lilly instead of Novo Nordisk, which could also have a positive impact on Lilly's stock price. Looking at a longer timeline, after 6 months of use, the average weight loss of patients using Lilly's Mounjaro was as high as 10.1%, while patients using Novo Nordisk's Ozempic only had an average weight loss of 5.8%. Mounjaro users had an average weight loss of 15.3% after 12 months, while Ozempic users had an average weight loss of 8.3%. The study also showed that the risk of gastrointestinal adverse events with the two weight loss injection drugs was similar