Prime Therapeutics lists four GLP-1 FDA decisions due by December
Four FDA decisions on GLP-1 drugs are expected by December, which could change what the labels cover and, later, what insurance plans pay for.
Prime Therapeutics' August 2026 pipeline update lists four FDA decisions on GLP-1 and related drugs expected before the end of this year, including what the pharmacy benefit manager calls the largest single catalyst left in 2026: an FDA decision on CagriSema for weight management, due in December [1].
The other three are a cardiovascular indication for Mounjaro (tirzepatide) in the third quarter of 2026, plus two fourth-quarter decisions — Foundayo (orforglipron) for type 2 diabetes and an Ozempic (semaglutide) 25 mg tablet [1]. Prime's update tracks pending regulatory actions that affect pharmacy coverage [1].
What is known about each
Novo Nordisk filed its CagriSema application in December 2025 and has guided to a decision by late 2026 [2]. The drug is a once-weekly combination of a GLP-1 and an amylin analog [2]. Novo disclosed 68-week results from the open-label REIMAGINE 4 trial alongside its second-quarter figures on August 4, 2026. The trial enrolled roughly 1,000 adults with type 2 diabetes that was inadequately controlled on metformin, with or without an SGLT2 inhibitor. CagriSema produced 15.2% weight loss and a 1.9 percentage point reduction in HbA1c on the efficacy estimand, compared with 15.8% and 2.2 percentage points for tirzepatide 15 mg. The combination met non-inferiority on weight loss but missed it on HbA1c. Both measures formed the dual primary endpoint, so the trial did not succeed on its stated terms [2]. Those figures were given in the quarterly financial report rather than in a standalone data release [2].
Orforglipron already has one US approval: the FDA cleared it for obesity in April 2026, and Lilly submitted the medicine for type 2 diabetes in the United States during the second quarter of 2026 [2]. In the UK, the MHRA authorised orforglipron on August 10, 2026 for weight management and type 2 diabetes, making the UK the first country in Europe to approve the tablet [2]. Lilly began UK supply on August 24 through private prescription only, with indicated private pricing of £100 to £120 per month; access through the National Health Service would require a separate evaluation by NICE [2].
The Ozempic 25 mg tablet entry is listed as a fourth-quarter decision, and what the application covers beyond that has not been reported [1]. Likewise, the Mounjaro entry is described as a cardiovascular indication, with no further detail on the filing [1].
Why it matters for patients
None of these decisions has happened yet, and none changes what is approved today [1]. What they can change is what a drug's label covers — and labels drive coverage. Insurance plans and pharmacy benefit managers typically review their formularies after FDA action, so a new indication can affect who qualifies for a drug and under what conditions.
For orforglipron, a US type 2 diabetes indication would add a second approved use to an existing obesity approval [2]. The tablet is taken once daily at any time of day with no food or water restrictions, a difference from oral semaglutide, which requires a fasting window [2].
The REIMAGINE 4 result is a mixed signal for CagriSema. It matched tirzepatide on weight loss in people with type 2 diabetes but fell short on blood sugar control [2]. How the FDA weighs that against the weight-management application is not known. A rejection or a narrow label would reset expectations for the amylin class [2].
Mounjaro's cardiovascular filing matters most to patients who have both type 2 diabetes and heart disease, since a cardiovascular indication would add a use to the label [1]. The specific patient population the filing targets has not been disclosed.
What happens next
A cardiovascular indication for Mounjaro is expected in the third quarter of 2026 [1]. On September 24, the Seventh Circuit hears oral arguments in Lilly's appeal against the FDA over how retatrutide is classified, a dispute that affects the application type and exclusivity length [2].
NICE's appraisal of orforglipron carries an expected publication date of November 18, 2026, after the committee requested more information from Lilly [2]. Foundayo for type 2 diabetes and the Ozempic 25 mg tablet are both listed for the fourth quarter of 2026 [1]. The CagriSema decision is expected in December 2026 [1]. Novo has also guided to a higher-dose CagriSema trial beginning in the second half of 2026, and Lilly plans to submit retatrutide to the FDA in the first quarter of 2027 [2].
Sources
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