Lilly Introduces Zepbound Single-Dose Vial for Cash-Paying Patients

Lilly has launched a single-dose vial model of Zepbound (tirzepatide) for self-pay sufferers. The one-dose is out there in 2.5 mg and 5 mg doses.

Zepbound is used to deal with adults who’re overweight as measured by physique mass index or those that are chubby and have hypertension, diabetes, or excessive ldl cholesterol. Tirzepatide can be out there with the identify Mounjaro to deal with adults with sort 2 diabetes.

Zepbound prompts receptors of hormones secreted from the gut — glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) — to scale back urge for food and meals consumption.

“In a medical examine, the 5 mg upkeep dose helped sufferers obtain a mean of 15% weight reduction after 72 weeks of therapy and has been a robust instrument for tens of millions of individuals with weight problems seeking to drop extra pounds and hold it off,” Patrik Jonsson, government vice chairman, and president of Lilly Cardiometabolic Well being and Lilly USA, stated in a information launch.

A four-week provide of the two.5 mg Zepbound single-dose vial is $399 ($99.75 per vial), and a four-week provide of the 5 mg dose is $549 ($137.25 per vial). Lilly officers stated this value is in keeping with the Zepbound financial savings program for non-covered sufferers. Lilly created the self-pay pharmacy part of LillyDirect the place sufferers with a legitimate prescription should buy Zepbound.

Zepbound can be out there in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 ml doses in a single-dose pen. The advisable upkeep dosages are 5 mg, 10 mg, or 15 mg injected subcutaneously as soon as weekly.

Zepbound launched in the USA to deal with grownup sufferers with weight problems or chubby with weight-related comorbidities in November 2023. For the primary six months of 2024, Zepbound generated gross sales of $1.76 billion

Final week, Lilly launched information from the SURMOUNT-1 three-year examine, which discovered that tirzepatide decreased the chance of growing sort 2 diabetes by 94% in adults with pre-diabetes and weight problems or who’re chubby. Tirzepatide resulted in sustained weight reduction via the therapy interval, averaging a 22.9% lower in physique weight with the 15 mg.

Tirzepatide was evaluated in 1,032 adults who had pre-diabetes at randomization and weight problems or chubby for a therapy interval of 176 weeks, adopted by a 17-week off-treatment interval (193 weeks in complete).

In a secondary endpoint, tirzepatide (10 mg and 15 mg) led to statistically important weight discount in contrast with placebo in adults with pre-diabetes and weight problems or chubby from baseline to week 176.

In the course of the 17-week off-treatment follow-up interval, those that had discontinued from tirzepatide started to regain weight and had some improve within the development to sort 2 diabetes, leading to an 88% discount within the threat of development to sort 2 diabetes in contrast with placebo.

Outcomes from the SURMOUNT-1 part 3 examine’s main evaluation at 72 weeks in all individuals had been printed within the New England Journal of Drugs in 2022.

Lilly has submitted tirzepatide to regulatory authorities in the USA and the EU to deal with grownup sufferers with moderate-to-severe obstructive sleep apnea with weight problems. Information launched in June 2024 present tirzepatide decreased moderate-to-severe obstructive sleep apnea severity by as much as 62.8%. In a key secondary endpoint from two medical research, 43.0% and 51.5% of individuals taking tirzepatide on the highest dose reached the standards for illness decision as outlined by apnea-hypopnea index and Epworth Sleepiness Scale measures.

Lilly continues analysis of tirzepatide for different ailments. Earlier this month, Lilly launched information from the SUMMIT part 3 trial displaying that tirzepatide decreased the chance of coronary heart failure outcomes – coronary heart failure pressing go to or hospitalization, oral diuretic intensification or cardiovascular demise – by 38% in contrast with placebo.

In metabolic dysfunction-associated steatohepatitis (MASH) — also called nonalcoholic steatohepatitis (NASH) — a part 2 trial of three totally different doses of tirzepatide resulted in decision of the illness and greater than half of sufferers achieved enchancment in fibrosis at 52 weeks, based on outcomes launched in June 2024.

These information had been introduced on the European Affiliation for the Research of the Liver (EASL) Congress 2024 and printed in The New England Journal of Drugs.

MASH is a extra superior type of nonalcoholic fatty liver illness (NAFLD), which is estimated to have an effect on about 30% adults in the USA. It’s a main reason for liver-related mortality, particularly for these with extra superior metabolic threat components corresponding to hypertension and kind 2 diabetes.