FDA Approves Mounjaro, a Novel Type 2 Diabetes Medication

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Lara Antal / Verywell

Key Takeaways

  • Eli Lilly’s Mounjaro, a once-a-week injection treatment for type 2 diabetes, recently gained FDA approval.
  • Experts say this medication represents a groundbreaking advancement in the diabetes community.
  • The drug targets two major hormones that regulate blood sugar levels.

The Food and Drug Administration (FDA) on May 13 approved Mounjaro (tirzepatide), a new injection treatment for type 2 diabetes.

Experts say Mounjaro represents an exciting advancement in diabetes management and it could benefit patients who need to lose weight.

Mounjaro, made by Eli Lilly, is the first diabetes medication to target both hormones that regulate blood sugar levels: glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Targeting GLP-1 and GIP can help patients lose weight and manage glucose levels.

Unlike insulin, which often requires two shots per day, Mounjaro can be self-administered once a week. It comes in six dosages, ranging from 2.5 mg to 15 mg.

“Having to do a once-weekly shot could improve medication adherence,” said Vivian N. Ayuk, PharmD, CDCES, CEO of health company Sorogi.

Ayuk added that the new treatment can lower glucose concentrations both during fasting and after meals, in addition to helping with weight management. “This really provides an additional tool in our toolbox for [patients] and also for their providers looking to offer the best therapy," she said.

In clinical trials, participants treated with Mounjaro lost between 12 and 25 pounds on average.

Patients who received the maximum recommended 15 mg of Mounjaro had a 1.6% reduction in hemoglobin A1c (HbA1c), an indicator of blood sugar level, more than the placebo group. Those who received Mounjaro and insulin saw a 1.5% reduction when compared to those who received a placebo plus insulin.

Whether Mounjaro will be prescribed alone or with insulin may depend on specific patient profiles, according to Ayuk. “It would all depend on where the patient is, what their ultimate goal is in terms of their care plan, and how this would fit in,” she said.

The treatment should be used in addition to a balanced diet and exercise routine, according to the FDA.

How to Take Mounjaro

Mounjaro will be available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) and it will come in Lilly’s auto-injector pen with a hidden needle that patients do not need to handle or see. It is administered once a week, at any time of the day.

It can be prescribed in addition to insulin, but the drug maker warns against mixing insulin and Mounjaro in the same injection.

Accessibility and Limitations of Mounjaro

Diabetes treatments are notoriously expensive—with or without insurance. Mounjaro’s list price is not yet available.

To access newer drugs like Mounjaro, Ayuk said, people who have Medicaid or Medicare sometimes need a prior authorization, which may require doctors to demonstrate that the drug is medically necessary for the patient.

Known Side Effects

The FDA does not recommend Mounjaro for people with personal or family history of medullary thyroid cancer, or who have multiple endocrine neoplasia syndrome type 2. The drug was shown to cause thyroid C-cell tumors in rats, and it is unknown whether it can cause such tumors or cancers in humans, according to the agency.

Mounjaro may also produce more general side effects like nausea, vomiting, diarrhea, decreased appetite, constipation, and abdominal discomfort or pain.

What This Means For You

People with type two diabetes may soon be able to get Mounjaro, a new FDA treatment, to help manage their condition. Depending on individual circumstances, the drug may be prescribed alone or along with other therapies.

1 Source
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  1. Food and Drug Administration. MOUNJAROTM (tirzepatide) injection, for subcutaneous use [drug label].

By Claire Wolters
Claire Wolters is a staff reporter covering health news for Verywell. She is most passionate about stories that cover real issues and spark change.