Wegovy, Ozempic and Mounjaro
Surging demand for drugmaker Novo Nordisk’s highly popular diabetes treatments Ozempic and Wegovy, now being used for weight loss, has created a major supply shortage that has left Americans empty handed. Lack of insurance coverage for these medications only exacerbates the difficulty of accessing these drugs for many who would want them.
Novo Nordisk admitted in a statement last month that demand for Wegovy “continues to outpace our increasing production” and it anticipates an “ongoing supply disruption,” though it pledged at the time to limit quantities of its lower dose versions of the drug “in an effort to support continuity of care of existing patients.”
The primary reason is a shortage of the drug semaglutide, the active ingredient in both diabetes treatments Ozempic and Wegovy. The drugmaker has admitted that it could take “some years” before the company fully meets demand for the drug. Unlike Wegovy, Ozempic and Eli Lilly’s diabetes treatment Mounjaro have not been approved as a weight loss drug, and so many insurance companies do not cover them for weight loss. Many don’t cover Wegovy even though it is approved for weight loss for the obese patient and those with health conditions exacerbated by their excess weight. Mounjaro, the brand name for the peptide tirzepatide, is attempting to complete studies that would allow it to receive FDA approval to treat obesity, which may open up insurance coverage options.
Novo Nordisk reported a 29% increase in sales over the first 6 months of 2023, resulting in “periodic supply constraints and related drug shortage notifications”. Shares of the stock of the company Novo Nordisk have climbed nearly 40% since the start of 2023. On August 8th the biggest ever one day of increase of 17% occurred after a promising large scale clinical trial of over 17,000 adults found Wegovy reduced the risk of major cardiovascular episodes by 20% in people over 45 who were study subjects.
Demand for Wegovy and Ozempic, nicknamed Hollywood’s worst kept secret, has surged in recent months because of its side effect of reducing adult’s appetite, leading to its use for weight loss, an off-label use.
Billionaire X owner Elon Musk attributed his weight loss to Wegovy, in a post last October. Wegovy, is a higher dose version of the semaglutide injection that acts by copying a hormone in the body that helps regulate appetite levels. It received approval for chronic weight management purposes from the FDA in June 2021. The approval made the once weekly injection available for adults who are overweight or obese, and who struggle from either high blood pressure, high cholesterol or type 2 diabetes. Earlier this month, Wegovy was also launched in the U.K, though Novo Nordisk released the disclaimer the the launch would be “controlled and limited” due to supply issues. Ozempic, on the other hand, has not received approval from the FDA for weight loss, though approved in 2017 to lower blood sugar levels in adults with type2 diabetes.
A note about “off label” use. Many people misunderstand the term off- label use, and it may suggest to some that there is something wrong with this type of prescribing by some doctors. Prescribing medications for “off-label” use is standard medical practice. An off label prescription is when a doctor prescribes a medication for a condition for which it has not received an FDA approval. And why would a doctor prescribe something for a condition for which it was not approved? When a medication receives FDA approval and then becomes widely used by physicians, the observation is often made that the medication may benefit a patient who has a different condition than the FDA approval was given for. In order to respond to the medical needs of their patients, doctors then use the medication for a different condition than it was approved for. If doctors did not do this they would be denying their patients a potentially important and valuable medication simply because the FDA process for approval had not been gone through for that condition. As a practical matter if the medical community were to wait for the medication to be approved for each condition that the medication could be used for, it could take years awaiting the results of those further studies to be done.
It is felt safe to prescribe drugs for an “off-label” use because when any new drug goes through the FDA approval process, it has to go through safety testing. Since the drug has already passed all the necessary tests proving its safety as, doctors are tasked with the responsibility of deciding when it is appropriate to prescribe the medication for a different condition than the one it was specifically approved for initially.