Approvals

Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Zepbound (tirzepatide) injection for chronic weight management, indicated for patients who are obese or overweight and have weight-related medical problems such as hypertension, dyslipidaemia, type 2 diabetes mellitus, obstructive sleep apnoea or cardiovascular disease (CVD).

It is recommended that the drug is used alongside a reduced-calorie diet and increased physical activity, and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines.

The approval follows results from the phase 3 SURMOUNT-1 and SURMOUNT-2 trials, in which patients taking Zepbound as an adjunct to diet and exercise experienced substantial weight loss compared to placebo. A third of patients on the drug lost over 58lb compared to only 1.5% on placebo.

Dr Leonard Glass, senior vice president global medical affairs, Lilly Diabetes and Obesity, commented: “Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice – something that people should manage themselves. For decades, diet and exercise have been a go-to, but it’s not uncommon for a person to have tried 20-30 times to lose weight with this approach. Research now shows that the body may respond to a calorie-deficit diet by increasing hunger and reducing feelings of fullness, making weight loss more difficult. Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”

Mike Mason, executive vice president and president, Lilly Diabetes and Obesity, added: “Far too many hurdles continue to prevent people living with obesity from accessing obesity treatments that could lead to significant weight loss. Broader access to these medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it.”

The drug is expected to be available in the US by the end of 2023 in six doses (2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and 15mg).