Biotech
Thursday, November 9th, 2023 7:01 pm EDT
Key Points
- The FDA has approved Eli Lilly’s drug tirzepatide, under the name Zepbound, for weight loss, allowing adults with obesity or those who are overweight with weight-related conditions to use it for chronic weight management. This approval comes after the drug was previously approved for treating Type 2 diabetes.
- Zepbound works by activating two hormones, GLP-1 and GIP, in the body, which slow stomach emptying, make people feel full for longer, and suppress appetite by reducing hunger signals in the brain.
- The drug’s approval positions Eli Lilly as a strong competitor to Novo Nordisk in the growing obesity drug market, with analysts estimating it could become a $100 billion industry by 2030. However, access and pricing remain challenges, with many insurers not covering weight loss drugs due to cost concerns.
The Food and Drug Administration (FDA) has granted approval for Eli Lilly’s drug tirzepatide, marking a significant development in the obesity treatment landscape in the United States. The active ingredient in tirzepatide has already received approval for the treatment of Type 2 diabetes as Mounjaro since May 2022. The new FDA approval enables adults with obesity or those who are overweight with at least one weight-related condition to utilize tirzepatide, which will be marketed as Zepbound, for chronic weight management. Zepbound is expected to be available in the U.S. by the end of the year, with a list price of approximately $1,060 per month’s supply.
Before this approval, many patients had been using tirzepatide off-label for weight loss, contributing to surging demand for treatments to aid in weight reduction, alongside drugs like Novo Nordisk’s Wegovy and Ozempic. All three of these drugs have faced supply constraints due to increased demand.
Eli Lilly’s entry into the obesity drug market intensifies the competition with Novo Nordisk, with Wall Street analysts estimating the market could reach $100 billion by 2030. The approval comes at a time when obesity affects an estimated 650 million adults worldwide, including roughly 40% of the U.S. adult population.
Zepbound is administered through a once-weekly injection, with the dosage gradually increased over 20 weeks to achieve target doses of 5, 10, or 15 milligrams per week. The drug works by activating two naturally produced hormones, GLP-1 and GIP, which slow stomach emptying, prolong feelings of fullness, and suppress appetite.
The FDA based its approval on late-stage trials of tirzepatide, which showed significant weight loss effects. In a study involving over 2,500 adults with obesity, those taking 5 milligrams of tirzepatide for 72 weeks lost an average of 16% of their body weight, with higher doses resulting in even more substantial weight loss. Another study indicated that tirzepatide led to a 15.7% weight loss in obese or overweight individuals with Type 2 diabetes.
However, access to tirzepatide and similar treatments remains a challenge, as many insurance companies do not cover weight loss drugs due to the high costs. Preliminary data suggests potential long-term heart health benefits from these drugs, but further research is required to determine their broader health benefits.
Zepbound is associated with side effects like nausea, diarrhea, vomiting, constipation, abdominal discomfort, fatigue, and allergic reactions. The drug has been linked to thyroid C-cell tumors in rats, although its effect on humans is unclear. The FDA advises against its use in patients with a history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 and warns against combining it with Mounjaro or another drug targeting GLP-1 due to unestablished safety and effectiveness. Additional warnings include pancreas inflammation, gallbladder issues, acute kidney injury, and the possibility of suicidal behavior or thinking. Patients using Zepbound are encouraged to monitor side effects and consult healthcare providers as necessary.
For the full original article on CNBC, please click here: https://www.cnbc.com/2023/11/08/fda-approves-eli-lilly-drug-tirzepatide-for-obesity.html
