The next stage of a high-stakes competition with competitor Eli Lilly for dominance of the lucrative obesity drug industry began on Monday when the Food and Drug Administration approved an oral form of Novo Nordisk’s weight-loss drug Wegovy.
The approval represents a paradigm change in the management of obesity. Weekly injections that can cause substantial weight loss now dominate the market.
Although the tablet versions of those medications appear to be slightly less effective, they are easier to swallow and have the potential to significantly increase usage.
Wall Street experts predict that by 2030, the combined sales of injectable and oral medications from this “GLP-1” class will exceed $100 billion annually.
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FDA Approval Reshapes the Obesity Drug Market
With the debut of oral Wegovy in early January, Novo will have an advantage. However, Eli Lilly’s experimental drug orforglipron, which passed late-stage testing this year and might be approved in a matter of weeks thanks to an FDA “national priority” designation, could quickly join it.
In a statement, Novo CEO Mike Doustdar declared, “The pill is here.” “We are thrilled about what this will mean for patients in the United States because no other oral GLP-1 treatment can match the weight loss provided by the Wegovy pill.”
The FDA and other federal health authorities have been under tremendous pressure from President Trump to increase the availability and quantity of obesity drugs.
Additionally, Novo and Lilly struck agreements with the White House to lower the cost of their medications for some Medicare recipients and cash payers. They also agreed to set the monthly initial doses of their oral medications at $149 as part of those agreements.
Political Pressure and Pricing Agreements Shape Access
Oral Wegovy’s entry for Novo follows a string of setbacks that have lowered the company’s share price and caused it to lose its top spot to Lilly. It is also the outcome of a change in strategy.
In 2023, many Phase 3 trials for the Wegovy pill, a higher-dose form of the oral GLP-1 it sells as Rybelsus for diabetes, were completed. However, Novo ignored regulatory filings at the time because it was having trouble keeping up with the growing demand for GLP-1 medications.
Additionally, Novo had given priority to an experimental dual-acting injectable medication; nevertheless, treatment with another potential oral medication produced unsatisfactory research results.
Novo has gathered more information for oral Wegovy and proceeded with a filing, even though the dual-acting medication, CagriSema, has since been submitted to regulators.
Strategic Shifts Behind Novo Nordisk’s Oral Wegovy
Wegovy was evaluated orally at doses up to 50 mg per day in Novo’s Phase 3 studies, known as OASIS.
The 25 mg dosage approved on Monday helped patients with obesity or overweight and related health issues lose an average of 14% of their body weight over 71 weeks, or 17% in those who wholly followed the treatment plans, according to the results of the most recent study, OASIS-4.
The 2.4 milligrams contained in the highest-dose weekly injection would be more than 50 times greater than the seven 25 mg daily dosages of a Wegovy pill over the course of a week.
The difficulties of getting a peptide medication like Wegovy through the digestive tract make that distinction necessary.
Orforglipron, on the other hand, is a chemical, or “small molecule,” medication that requires less complicated production. The maximum daily dose examined in clinical trials was 36 mg.
