The U.S. Food and Drug Administration (FDA) has approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes (T2D), as an addition to diet and exercise. The drug, manufactured by Eli Lilly, improved blood sugar more effectively than the other diabetes therapies that were included in the clinical studies that were the basis for its approval, according to the FDA statement, released on May 13.
Its estimated that more than 37 million people in the United States have type 2 diabetes, according to the Centers for Disease Control and Prevention (CDC). People with T2D are twice as likely to have heart disease or stroke compared to someone without diabetes, and at a younger age, per the agency.
Given the challenges many patients experience in achieving their target blood sugar goals, todays approval of Mounjaro is an important advance in the treatment of type 2 diabetes, said Patrick Archdeacon, MD, associate director of the division of diabetes, lipid disorders, and obesity in the FDAs Center for Drug Evaluation and Research, in the statement.
The drug is the first approved medication that targets two principal natural incretin hormones, GIP and GLP-1. Incretins are metabolic hormones that stimulate a decrease in blood glucose levels.
The approval was based on results from the phase 3 SURPASS program, which included head-to-head comparisons to the injectable Ozempic (semaglutide) 1 milligram (mg), as well as comparisons with long-acting insulin analogs Lantus (insulin glargine) and Tresiba (insulin degludec). At the end of seven different phase 3 trials that lasted between 40 and 52 weeks, Mounjaro produced superior A1C reductions versus all comparators.
Mounjaro appears to represent an advancement over current GLP-1 analogues, providing enhanced glycemic and weight benefits without an added penalty in terms of gastrointestinal adverse effects, stated a commentary response published in July 2021 in The Lancet after the publication of one of the phase 3 trials.
Mounjaro has not been studied in patients with a history of pancreatitis and is not indicated for use in patients with type 1 diabetes mellitus.
Many of the participants in the Mounjaro trials also had overweight or obesity; the average BMI was 32 to 34 at the time of trial enrollment. A BMI of 30 or higher is in the obesity range, according to the CDC.
While the drug is not indicated for weight loss, average change in body weight was a secondary endpoint in all SURPASS studies, and participants lost between 12 and 25 pounds on average.
Eli Lilly is seeking approval for tirzepatide for weight loss, and the company recently announced results from a phase 3 trial testing. Participants (all with either overweight or obesity, but not diagnosed with type 2 diabetes) received the medication or a placebo over the course of 72 weeks, along with support to follow a calorie-restricted diet and to increase physical activity levels. On the highest dose (15 mg) participants had an average weight loss of 22.5 percent of their body weight 52 pounds.
Side effects reported in 5 percent or more of people taking Mounjaro included nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort, and abdominal pain.
The drug carries a warning for a risk of thyroid C-cell tumors, as Mounjaro causes thyroid C-cell tumors in rats. It is unknown whether Mounjaro causes such tumors, including medullary thyroid cancer, in humans. According to the prescribing information, Mounjaro should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia syndrome type 2.
Mounjaro will be available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg) and will come in an auto-injector pen with a pre-attached, hidden needle that patients do not need to handle or see. The medication is self-administered one time each week and can be injected under the skin of the stomach, thigh, or upper arm.
According to a May 13 release from the company, Mounjaro is expected to be available in the United States in the coming weeks. No information has been released about how much the drug will cost.
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FDA Approves Mounjaro, a Novel Once-a-Week Medication to Treat Type 2 Diabetes - Everyday Health
