Gli Amanti

FDA Approves “An Important Advance,” Tirzepatide

Yesterday, FDA approved tirzepatide for type 2 diabetes, calling it “an important advance.” The brand name will be Mounjaro. This is the same drug for which its maker, Eli Lilly and Company, announced remarkable results in a phase 3 obesity study barely two weeks ago. It is the first of its kind – a dual GIP and GLP-1 agonist.

Dual Action

Perhaps the dual action of this new drug is the reason why Lilly has seen such remarkable effectiveness for tirzepatide. In approving it, the agency notes that it was “more effective than other diabetes therapies with which it was compared.” Patrick Archdeacon is the FDA’s associate director of the Division of Diabetes, Lipid Disorders, and Obesity. In a press release from the agency, he said:

“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.”

This is praise that commands our attention.

Dual Significance

But the tirzepatide approval is also an important milestone that marks looming competition for obesity therapy. We say this because it will put pricing pressure on Novo Nordisk, which has been extracting a premium price for its advanced obesity therapies therapies as compared to the prices it charges for the same drugs in diabetes.

This higher price for obesity has been possible because the dosing of semaglutide (Wegovy, the Novo Nordisk product) is different in obesity and diabetes. So it is sold in different injection pens for the different indications and the pen for obesity carries a 51 percent higher price.

In contrast, tizepatide dosing for diabetes and obesity appears to be the same – 5, 10, or 15 mg. That will make it tougher to stick a higher price on an obesity branded form of this drug. Diabetes therapy is a larger, more competitive market. So we have reason to hope that competitive pressures will keep a check on the tendency for pharma to drive costs higher. No guarantees, but reasons to hope.

Innovation is good. Especially when it brings competition, better value, and better options for obesity care.

Tirzepatide for obesity is likely two years away, but we will await it eagerly.

Click here for the full prescribing information for tirzepatide and here for FDA’s press release about it. For Lilly’s press release, click here. You can find further reporting here, here, and here.

Gli Amanti, painting by Gerardo Dottori / WikiArt

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May 14, 2022