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New diabetes drug approved by the FDA

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Adults with Type-2 diabetes now have a new medication to discuss with their doctors.

The Food and Drug Administration has granted Eli Lilly and Co. approval for Mounjaro (tirzepatide), an injection that can improve blood sugar control.

Type 2 diabetes is the most common type with more than 30-million Americans diagnosed. It can be a progressive condition with the patient’s body unable to make or use insulin normally, creating high levels of glucose in the blood. The Mayo Clinic lists eight injectable medications and 18 oral medications for treating diabetes.

“Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” said Dr. Patrick Archdeacon, associate director of the Division of Diabetes, Lipid Disorders and Obesity in the FDA’s Center for Drug Evaluation and Research, in a news release.

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The FDA report said clinical studies found Mounjaro was more effective at improving blood sugar levels than the current medications.

Dr. Matthew Nicholson. Courtesy
Augusta University Health.

Dr. Matthew Nicholson is an endocrinologist at the Medical College of Georgia and AU Health. He is also associate director of the Augusta Diabetes Center. He said approval of a new medication is a big deal.

“So, over the last five, six years, we had two classes available, one called GLP-1 and another one called SGLT-2 inhibitors,” he said. “This newer one takes the GLP1 class and actually adds it into another class, because it works on two different types of hormones in the gut. We saw a lot of weight loss benefit from our GLP-1 medications and this new one has even more weight loss benefit with probably less of some of the side effects that we were seeing.”

Studies found patients using current drugs like Ozempic, Jardiance and Trulicity lost an average of 12 pounds.

Mounjaro is a once-a-week, under the skin injection of 5 milligrams, 10 milligrams or 15 milligrams. It can be used on its own or as an add-on to other diabetes medicines.

Nicholson said patients on the lower dosage lost an average of 13 pounds while those on the higher dosage, particularly the 15 milligrams lost as much as 25 pounds.

“People can do this stuff with diet, but these new drugs are good, because sometimes it does help them just kickstart that motivation and helps them push through parts of the diet where they struggle, because they affect appetite,” he said. “We’ve had people who say “I used to always have another sandwich right before bed. And while on this, I just, I don’t even desire it, I don’t even crave it.’”

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The FDA reports side effects can include nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain.

The report said Mounjaro causes thyroid C-cell tumors in rats, but it is unknown if it will do so in humans. However, it recommends the drug not be used by patients with a personal or family history of medullary thyroid cancer. It is also contraindicated for patients with Multiple Endocrine Neoplasia syndrome type 2.

“Rats can develop these tumors of the thyroid, from the T cells and the thyroid. In humans, those cells don’t do a whole lot, but in rats, they’re more abundant. They saw some receptors, where they are concerned that maybe those receptors if you gave them a GLP-1 it might make those T cells grow,” Nicholson said. “To date, they have not actually in a single human caused medullary thyroid cancer or caused someone to develop in the in type two, it’s just in theory. We don’t want to test that theory.”

Mounjaro received priority review designation from the FDA, which directs attention and resources to drugs that result in significant improvements in the treatment, or prevention of serious conditions.

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That is part of what Nicholson finds exciting and impactful about the development of new drug therapies, like Mounjaro.

“People are actually starting to say, ‘Okay, you have diabetes, and in the past, well, just eat better.’ But you realize that’s not that easy,” he said “So, for the drug companies coming out and making more drugs for it, especially ones that have affect all the other issues like weight and heart attacks and stroke, you know, it’s really nice, because instead of just managing and maintaining someone diabetes, we’re starting to see where we’re reversing diabetes, and we’re reducing risks of heart attacks and strokes.”

Mounjaro is not for use by patients with Type-1 diabetes.

Dana Lynn McIntyre is a general assignment reporter for The Augusta Press. Reach her at [email protected] 

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