The Food and Drug Administration has approved a higher-dose version of the weight-loss drug Wegovy through a pilot program designed to accelerate drug approvals.
The agency said Thursday that 7.2-milligram injectable doses of Wegovy are now approved for certain adult patients. Those eligible include people with obesity and overweight patients with at least one underlying health condition.
The drug is available only after a patient has tolerated a 2.4-milligram dose of Wegovy for four weeks and additional weight loss is clinically indicated.
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Novo Nordisk said 31.2% of people on the higher dosage achieved weight loss of at least 25% of their body weight, compared with about 15% of patients on the 2.4-milligram dose. Practically no patients on a placebo lost 25% of their weight.
The FDA approved the higher dose 54 days after Novo Nordisk applied, making it just the fourth drug to be cleared through the Commissioners National Priority Voucher pilot program.
The program aims to shorten the approval process for certain medicines from 10 to 12 months to under two months. It was created to address public health crises, large unmet health needs, affordability concerns or innovative breakthrough therapies.
The new FDA is moving with unprecedented efficiency on products that advance national priorities, said FDA Commissioner Martin Makary. Todays approval is another demonstration of what the FDA can accomplish when we try bold new things.
The higher-dose Wegovy is expected to be available in pharmacies starting in April.
GLP-1 medications have been used for decades to treat diabetes and have recently gained popularity for weight loss. In addition to helping people with diabetes control symptoms, drugmakers say GLP-1 medicines improve cardiometabolic markers in both diabetic and non-diabetic patients with obesity.
According to the Cleveland Clinic, GLP-1 medications manage blood sugar by triggering insulin release from the pancreas and slowing digestion, which reduces the amount of glucose entering the bloodstream. They also help patients feel full after eating.
Potential risks include gastrointestinal issues, headaches, sore throat and fatigue, which were observed during clinical trials.
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