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Diabesity Solutions: Innovations & Market Moves
- Jana Chisholm
- Nov 16, 2025
- 5 min read
We're keeping Eyes On Diabesity. With new approvals, data on the horizon, and M&A to bolster pipelines, it seems like there's something new everyday. Here we cover new MACE indications and the Metsera bidding war. What were you watching?
Following the FDA’s approval of Novo Nordisk’s semaglutide medications Ozempic and Wegovy to lower the risk of serious adverse cardiovascular events (MACE), the agency has expanded the MACE for its semaglutide pill Rybelsus. For patients with Type 2 diabetes who would rather take Novo’s GLP-1 pills than its injectable forms, the approval is welcome. Additionally, it creates a benchmark for oral medications that are presently being developed in the field. To lower the risk of cardiovascular mortality, heart attack, or stroke in persons with Type 2 diabetes who are more susceptible to these events, the FDA approved Rybelsus tablets at 7 mg and 14 mg. Five weeks after the EMA extended the use of Rybelsus to the same patient group, the approval was made.
A phase 3 trial involving 9,650 persons with Type 2 diabetes who either had established cardiovascular disease or chronic renal disease served as the basis for the approval. Time to first incidence of a MACE event (cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke) was the main outcome.
The results showed that, in comparison to a placebo, the 14 mg dose of Rybelsus decreased the risk of MACE by 14%. Over a four-year follow-up period, MACE happened in 12% of Rybelsus patients and 13.8% of placebo patients. 559 participants (11.6%) in the placebo group and 749 participants (15.5%) in the Rybelsus group experienced adverse events that resulted in cessation; the majority of those who dropped out reported gastronomical issues.
In the first half of this year, Rybelsus made 11.3 billion Danish kroner ($1.7 billion), although it was eclipsed by Novo’s mega-blockbuster Ozempic and Wegovy. When various anti-diabetic medications failed to help patients with Type 2 diabetes reach their A1C target, Rybelsus was first authorised in 2019. Its usage as a first-line therapy for Type 2 diabetes was approved by the FDA in 2023. Rybelsus is another medication that Novo is studying to lower the risk of heart failure. Wegovy received its MACE nod in 2020, while Ozempic received it in 2024.
Eli Lilly, Novo’s main competitor in the market, has not yet received a MACE approval for its dual-action tirzepatide medicines. Zepbound, a therapy for obesity, is being tested by the business in the phase 3 Surmount-MMO trial. Lilly presented the findings of the phase 3 Surpass-CVOT study three months ago, showing that Mounjaro was not inferior to its GLP-1 Trulicity in terms of lowering the risk of MACE. Lilly intends to submit Mounjaro for approval by the end of this year in order to lower the risk of MACE, despite analysts finding the results to be unimpressive.
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Novo Nordisk has surprised Pfizer by trying to outbid the American pharmaceutical company for the obesity biotech Metsera. After the Big Pharma announced more than a month ago that the biotech’s board had unanimously approved the sale of the company for $4.9 billion, with an additional $2.4 billion on the table in relation to certain milestones, Pfizer’s acquisition of Metsera had seemed to be finalised until this week.
MET-097i, a phase 2b injectable GLP-1 receptor agonist that may enable monthly dosage, is at the forefront of Metsera’s pipeline advancement. The biotech’s clinical-phase pipeline also includes an oral GLP-1 that is intended to promote greater weight reduction than small molecules and circumvent the scalability issues of other oral peptides, as well as a monthly injectable amylin analogue that may be used in conjunction with MET-097i. By offering Metsera stockholders an equity value of $6.5 billion for the biotech, with an additional $2.5 billion contingent on milestones, Novo has now made the bold decision to upend the status quo. Pfizer fought back, calling Novo’s offer an unprecedented and dangerous proposition that does not meet the requirements of Pfizer’s agreement with Metsera to be considered a superior offering. Pfizer is willing to take legal action in any way possible.
Pfizer asserted that Metsera had earlier rejected an offer from Novo and chose Pfizer because of the increased assurance that the American pharmaceutical company could acquire all of the biotech’s stock. According to Pfizer, the deal assures that Metsera’s significant medicine candidate can become a major competitor accessible to all Americans in this crucial therapeutic field and generates genuine, guaranteed, and instant value for its investors. Metsera seems to have a different opinion. When combined with the associated milestone payments, Novo’s offer would reach an equity value of almost $9 billion, according to the biotech, which characterised it as better.
Metsera clarified that it has now given Pfizer four working days to make a more alluring offer; nevertheless, Pfizer has maintained that Metsera is not free to terminate the current agreement. Metsera doesn't share Pfizer's opinion. For both Big Pharmas, the surprise announcement comes at a delicate time. It poses a challenge to Pfizer’s well-publicized comeback into the obesity market following a string of clinical disappointments that eliminated its initial weight loss portfolio.
It is Novo’s most audacious move to date under newly appointed CEO Maziar Mike Doustdar. Doustdar has previously made plans to fire roughly 9,000 workers globally and stop its cell therapy research and development in response to a halt in sales growth for its popular obesity medication Wegovy. In an explanation of their surprising offer at the end of October, Novo stated that purchasing Metsera would allow the pharmaceutical company to fully utilise the complementary portfolio and skills of Metsera. The acquisition would be consistent with Novo Nordisk’s long-term plan to create novel, unique medications and treat millions of individuals with diabetes, obesity, and related comorbidities.
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Updated to add:
Metsera accepted a sweetened offer from Pfizer late on 7th November 2025, citing U.S. antitrust risks in Novo's bid that it had previously called superior. The Danish obesity drug behemoth said on Saturday it would exit the race.
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