Our Take: Lilly scores FDA approval of tirzepatide for weight management, intensifying rivalry with Novo Nordisk
Eli Lilly’s tirzepatide, which the FDA approved last year as a treatment for type 2 diabetes, is now also approved for chronic weight management.
Lilly markets the drug under the brand name Mounjaro for diabetes but will use the brand name Zepbound for the weight-management product, which the company anticipates will be available by the end of this year.
The target doses (5 mg, 10 mg, and 15 mg) are the same for both products, and Mounjaro has been used off-label for treating obesity since it was approved.
Zepbound will have a list price of approximately $1,060 for a month’s supply, which Lilly said is about 20% lower than Novo Nordisk’s Wegovy (semaglutide) 2.4 mg injection (approximately $1,350).
With the commercial savings card program Lilly is implementing, people with commercial insurance that covers Zepbound could be eligible to pay as little as $25 for a one-month or three-month prescription, Lilly said, and those with commercial insurance that does not cover Zepbound could be eligible to pay as low as $550 for a one-month prescription.
Zepbound is indicated for adults with obesity (those with a body mass index of at least 30 kg/m2) or adults who are overweight (with a BMI of at least 27 kg/m2) who also have a weight-related health condition, such as hypertension, high cholesterol, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease, “to lose weight and keep it off,” Lilly said in a press release. The drug is to be used in conjunction with a reduced-calorie diet and increased physical activity.
According to Lilly, Zepbound is “the first and only obesity treatment of its kind” that activates two incretin hormone receptors — glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Like Novo Nordisk’s Wegovy, Zepbound is administered as a once-weekly subcutaneous injection. Lilly said Zepbound will be available in six doses ranging from 2.5 mg to 15 mg. When initiating treatment, the dose must be up-titrated over four to 20 weeks until the target dosage of 5 mg, 10 mg, or 15 mg is achieved.
Lilly noted that the use of Zepbound may sometimes be associated with severe gastrointestinal adverse reactions. Labeling for Zepbound includes warnings pertaining to multiple health conditions and a boxed warning regarding thyroid C-cell tumors.
Our Take: The FDA approved Novo Nordisk’s semaglutide product for type 2 diabetes, Ozempic, in 2017, followed by Wegovy for weight management in 2021, giving the Danish drugmaker a considerable head start over Lilly in both indications.
Demand has outpaced Novo Nordisk’s ability to supply the drug, and off-label use of Ozempic for weight loss has at times resulted in a shortage of the drug for patients with diabetes. Lilly has also had difficulty keeping up with demand for Mounjaro, in part because of its off-label use for weight loss.
According to the Centers for Disease Control and Prevention, the prevalence of obesity in the U.S. is now 4 in 10 adults. Add in adults who are overweight, and the prevalence climbs to approximately 70%, according to the FDA.
In light of these numbers, it would seem there’s enough demand to keep both Novo Nordisk and Lilly scaling up their manufacturing capabilities for quite some time — while earning billions of dollars per quarter.
Barron’s said the cost of Wegovy and Zepbound “could provoke a spending crisis,” given the demand for the drugs.
But, their cost could place them out of reach for many people who could benefit from them, Barron’s said. Although several large health insurers cover Wegovy, not many smaller ones do, and Medicare is prohibited from providing coverage for weight-loss treatments. Medicaid coverage for Wegovy is limited.
Meanwhile, Lilly is investigating the use of tirzepatide as a treatment for obstructive sleep apnea, chronic heart failure with preserved ejection fraction and non-alcoholic steatohepatitis (NASH). The company is also developing an oral version of tirzepatide and has a next-generation oral GLP-1 agonist, orforglipron, in Phase III clinical development for obesity and diabetes. Lilly’s pipeline also has a Phase II candidate called retatrutide in development for diabetes and obesity that acts as a triagonist for GIP receptor, the GLP-1 receptor, and the glucagon receptor.
In addition to developing an oral version of semaglutide, Novo Nordisk is evaluating the drug as a potential treatment for NASH and for Alzheimer’s disease.
Wegovy also appears to have cardio-protective benefits beyond those expected in connection with weight loss, based on trial results presented over the weekend at the American Heart Association annual Scientific Sessions in Philadelphia.
Novo Nordisk also has a long-acting co-agonist of GLP-1 and amylin, called amycretin, that’s in early-stage development as a once-daily oral treatment for obesity.
AstraZeneca, who scrapped development of a couple of GLP-1 agonists earlier this year, agreed last week to pay Chinese biotech Eccogene $185 million up front for a next-generation oral GLP-1 receptor agonist in development as a treatment for obesity, type 2 diabetes, and other cardiometabolic conditions.
Pfizer discarded one of its experimental obesity treatments earlier this year, too, because of liver safety concerns, but is continuing development of a candidate called danuglipron. The compound is in Phase II testing as a treatment for both obesity and type 2 diabetes.
In many ways, it seems as though the potential market for the current and future weight-loss drugs is on the verge of exploding. More than one expert has referred to the drugs as game changers, and entire industries — like food and travel, for example — could feel the ripple effects. Denmark’s economy already has, thanks to the profits Novo Nordisk has brought in from Wegovy and Ozempic.
The game-changing nature of these drugs isn’t just because of their ability to curb appetite; it’s for all of the additional potential uses for other cardiometabilic conditions. And if it reduces the urge to eat, could it also be used in the management of other addictive behavior?
Drugs like Enbrel (Amgen) and Humira (Abbvie) achieved eye-popping sales because of their Swiss Army knife-like ability to treat so many conditions beyond their original indications. Are we seeing another crop of drugs with similar potential?
Food for thought.
Disclosure: Amgen, AstraZeneca, and Novo Nordisk are Darwin Research Group clients.
What else you need to know
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What we’re reading
Untapped opportunities for health system pharmacies. McKinsey & Company, 11.7.23
Primary Care Redesign for Value-Based Care. NEJM Catalyst, 11.3.23 (summary available, subscription required for full article)
From Training To Trapping: The Paradox Of Training Repayment Agreements In Nursing. Health Affairs, 11.7.23