MOUNJARO® (TIRZEPATIDE), THE FIRST AND ONLY SINGLE MOLECULE GIP AND GLP-1 RECEPTOR AGONIST FOR THE TREATMENT OF ADULTS WITH TYPE 2 DIABETES IS NOW AVAILABLE IN CANADA

• Mounjaro delivered superior HbA1c reductions versus Ozempic (semaglutide) 1 mg in the phase 3 SURPASS-2 clinical trial
• While not indicated for weight management, Mounjaro led to significantly greater weight reductions versus the comparator, Ozempic 1 mg, as a key secondary endpoint
• Mounjaro represents the first new class of diabetes medicines introduced in nearly a decade and is now available for Canadian patients

TORONTO, Nov. 2, 2023 /CNW/ - Lilly Canada is pleased to announce that Mounjaro^® (tirzepatide) is now available in Canada. Mounjaro is a new once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist, and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. 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 and is not indicated for weight management.

As the first and only Health Canada-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones.¹

"Since the results of the SURPASS clinical trial program were released, the Canadian type 2 diabetes community has been eagerly awaiting the availability of tirzepatide (Mounjaro), and now the wait is over! It is great news to have another option to offer people living with type 2 diabetes who can benefit from lower blood sugar levels," says Dr. Alice Cheng, Diabetes Specialist and Associate Professor at the University of Toronto.

Mounjaro is available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) and will come in single-use, single-dose vials.

Health Canada approval was based on results from the phase 3 SURPASS program, which included active comparators of injectable semaglutide 1 mg, insulin glargine and insulin degludec. Efficacy was evaluated for Mounjaro 5 mg, 10 mg and 15 mg used alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas, and insulin glargine. Participants in the SURPASS program achieved average HbA1c reductions between 1.8 per cent and 2.1 per cent for Mounjaro 5 mg and between 1.7 per cent and 2.4 per cent for both Mounjaro 10 mg and Mounjaro 15 mg. Mounjaro is not indicated for weight management. Mean change in body weight was a key secondary endpoint in all SURPASS studies. Participants treated with Mounjaro lost between 5.4 kg (12 lb) with Mounjaro 5 mg and 11.3 kg (25 lb) with Mounjaro 15 mg) on average.²

"We are absolutely thrilled to see this groundbreaking new class of diabetes medicines now available to people living with type 2 diabetes in Canada. It marks a significant milestone in the mission to improve the lives of those living with diabetes," says Deborah Dugan, CEO of Beyond Type 1 and Beyond Type 2. "We applaud the companies, researchers, medical professionals and all involved who work tirelessly to make these innovations possible."

Side effects reported in at least 5 per cent of patients treated with Mounjaro included nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion (dyspepsia), and stomach (abdominal) pain. The labeling for Mounjaro contains a boxed warning regarding thyroid C-cell tumours in rodents. The human relevance has not been determined. Mounjaro is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2, and in pregnancy or breastfeeding.³

"Lilly has been committed to improving lives for people for diabetes for more than 100 years; our founder believed in challenging the status quo for patients, and this patient-centric approach drives meaningful innovation with treatments like Mounjaro," says Kenneth Custer, President and General Manager, Lilly Canada. "Mounjaro represents the first treatment in a new class of medicines to help Canadians with type 2 diabetes achieve glycemic control."

Mounjaro is now available in Canada.  Lilly is committed to helping people access the medicines they are prescribed, and will work with insurers, health systems and providers to help enable patient access to Mounjaro. Lilly offers a Patient Support Program for eligible patients. Patients or healthcare professionals with questions about Mounjaro can visit www.Mounjaro.ca or call the Lilly Customer Response Centre at 1-888-545-5972.

About the SURPASS clinical trial program

The SURPASS phase 3 global clinical development program for tirzepatide began in late 2018 and included five global registration trials and two regional trials in Japan. These studies ranged from 40 to 52 weeks and evaluated the efficacy and safety of Mounjaro 5 mg, 10 mg and 15 mg as a monotherapy and as an add-on to various standard-of-care medications for type 2 diabetes. The active comparators in the studies were injectable semaglutide 1 mg, insulin glargine and insulin degludec. Collectively, the five global registration trials consistently demonstrated HBA1C reductions for participants taking Mounjaro across multiple stages of their type 2 diabetes journeys, from an average around five to 13 years of having diabetes.⁴

• SURPASS-1 (NCT03954834) was a 40-week study comparing the efficacy and safety of Mounjaro 5 mg (N=121), 10 mg (N=121) and 15 mg (N=120) as monotherapy to placebo (N=113) in adults with type 2 diabetes inadequately controlled with diet and exercise alone. From a baseline HBA1C of 7.9 per cent, Mounjaro reduced participants' HBA1C by a mean of 1.8%* (5 mg) and 1.7 per cent* (10 mg and 15 mg) compared to 0.1 per cent for placebo. In a key secondary endpoint, from a baseline weight of 85.9 kg (189 lb.), Mounjaro reduced participants' weight by a mean of 6.3 kg (14 lb.) * (5 mg), 7.0 kg (15 lb.)* (10 mg) and 7.8 kg (17 lb.)* (15 mg) compared to 1 kg (2 lb.) for placebo.
• SURPASS-2 (NCT03987919) was a 40-week study comparing the efficacy and safety of Mounjaro 5 mg (N=470), 10 mg (N=469) and 15 mg (N=469) to injectable semaglutide 1 mg (N=468) in adults with type 2 diabetes inadequately controlled with ≥1500 mg/day metformin alone. From a baseline HBA1C of 8.3 per cent, Mounjaro reduced participants' HBA1C by a mean of 2.0 per centꝉ (5 mg), 2.2 per cent* (10 mg) and 2.3 per cent* (15 mg) compared to 1.9 per cent for semaglutide. In a key secondary endpoint, from a baseline weight of 93.7 kg (207 lb.), Mounjaro reduced participants' weight by a mean of 7.6 kg (17 lb.)ꝉ (5 mg), 9.3 kg (21 lb.)* (10 mg) and 11.2 kg (25 lb.)* (15 mg) compared to 5.7 kg (13 lb.) for semaglutide 1 mg.
• SURPASS-3 (NCT03882970) was a 52-week study comparing the efficacy of Mounjaro 5 mg (N=358), 10 mg (N=360) and 15 mg (N=358) to titrated insulin degludec (N=359) in adults with type 2 diabetes treated with metformin with or without an SGLT-2 inhibitor. From a baseline HBA1C of 8.2 per cent, Mounjaro reduced participants' HBA1C by a mean of 1.9 per cent* (5 mg), 2.0 per cent* (10 mg) and 2.1 per cent* (15 mg) compared to 1.3 per cent for insulin degludec. From a baseline weight of 94.3 kg (208 lb.), Mounjaro reduced participants' weight by a mean of 7.0 kg (15 lb.)* (5 mg), 9.6 kg (21 lb.)* (10 mg) and 1.3 kg (25 lb.)* (15 mg) compared to an increase of 1.9 kg (4 lb.) for insulin degludec.
• SURPASS-4 (NCT03730662) was a 104-week study comparing the efficacy and safety of Mounjaro 5 mg (N=328), 10 mg (N=326) and 15 mg (N=337) to insulin glargine (N=998) in adults with type 2 diabetes inadequately controlled with at least one and up to three oral antihyperglycemic medications (metformin, sulfonylureas or SGLT-2 inhibitors), who have increased cardiovascular (CV) risk. The primary endpoint was measured at 52 weeks. From a baseline HBA1C of 8.5 per cent, Mounjaro reduced participants' HBA1C by a mean of 2.1 per cent* (5 mg), 2.3 per cent* (10 mg) and 2.4 per cent* (15 mg) compared to 1.4 per cent for insulin glargine. From a baseline weight of 90.3 kg (199 lb.), Mounjaro reduced weight by a mean of 6.4 kg (14 lb.)* (5 mg), 8.9 kg (20 lb.)* (10 mg) and 10.6 kg (23 lb.)* (15 mg) compared to an increase of 1.7 kg (4 lb.) for insulin glargine.
• SURPASS-5 (NCT04039503) was a 40-week study comparing the efficacy and safety of Mounjaro 5 mg (N=116), 10 mg (N=118) and 15 mg (N=118) to placebo (N=119) in adults with inadequately controlled type 2 diabetes already being treated with insulin glargine, with or without metformin. From a baseline HBA1C of 8.3 per cent, Mounjaro reduced HBA1C by a mean of 2.1 per cent* (5 mg), 2.4 per cent* (10 mg) and 2.3 per cent* (15 mg) compared to 0.9 per cent for placebo. From a baseline weight of 95.2 kg (210 lb.), Mounjaro reduced participants' weight by a mean of 5.4 kg (12 lb.)* (5 mg), 7.5 kg (17 lb.)* (10 mg) and 8.8 kg (19 lb.)* (15 mg) compared to an increase of 1.6 kg (4 lb.) for placebo.

*p<0.001 for superiority vs. placebo or active comparator, adjusted for multiplicity ꝉp<0.05 for superiority vs. semaglutide 1 mg, adjusted for multiplicity

About Mounjaro^® (tirzepatide) injection⁵

Mounjaro^® (tirzepatide) is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As the first and only Health Canada-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1).

About Lilly Canada

Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

REFERENCES

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¹ Mounjaro Canadian Product monograph.

² Mounjaro Canadian Product monograph.

³ Mounjaro Canadian Product monograph.

⁴ Rosenstock, J, et. al. Efficacy and Safety of Once Weekly Tirzepatide, a Dual GIP/GLP-1 Receptor Agonist Versus Placebo as Monotherapy in People with Type 2 Diabetes (SURPASS-1). Abstract 100-OR. Presented virtually at the American Diabetes Association's 81st Scientific Sessions; June 25-29.

Rosenstock, J, et. al. (2021). Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6.

Frías JP, Davies MJ, Rosenstock J, et al; for the SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6)(suppl):503-515. doi: 10.1056/NEJMoa2107519

Frias, J.P. Efficacy and Safety of Tirzepatide vs. Semaglutide Once Weekly as Add-On Therapy to Metformin in Patients with Type 2 Diabetes. Abstract 84-LB. Presented virtually at the American Diabetes Association's 81st Scientific Sessions; June 25-29.

Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. doi: 10.1016/S0140-6736(21)01443-4

Del Prato S, Kahn SE, Pavo I, et al; for the SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. doi: 10.1016/S0140-6736(21)02188-7

Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. doi:10.1001/jama.2022.0078

⁵ Mounjaro Canadian Product Monograph.

SOURCE Eli Lilly Canada Inc.

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