Denmark-based drugmaker Novo Nordisk cleared the U.S. approval hurdle for an "oral Wegovy," kicking off a structural shift in the obesity-treatment market.
This is the first time a glucagon-like peptide-1 (GLP-1) obesity treatment, which has been wildly popular in the United States and Korea, has been released as an oral drug. GLP-1 obesity treatments mimic the GLP-1 hormone, which stimulates insulin secretion and slows digestion, to deliver weight-loss effects.
In Dec., the U.S. Food and Drug Administration (FDA) approved Novo Nordisk's oral Wegovy (wegovy pill, active ingredient semaglutide). The company has begun sales in the United States and is moving to expand the market.
Until now, the GLP-1 obesity treatment market has centered on injectables. The industry expects that the launch of an oral drug is more than a simple formulation change and will serve as a catalyst to simultaneously improve patient access and reshape the industry structure.
Emil Kongshøj Larsen, executive vice president at Novo Nordisk headquarters, told ChosunBiz at the JPMorgan Healthcare Conference in San Francisco on Jan. 13 that "based on initial launch markets, by 2030 roughly one-third of GLP-1 obesity patients could choose an oral therapy." This is an upward revision from the company's outlook one to two years ago.
The basis is clinical efficacy. Larsen said, "Oral semaglutide (oral Wegovy) has strong clinical data showing weight-loss efficacy and cardiovascular protection comparable to injectables," adding, "A large share of patients will likely choose an oral drug." In the OASIS-4 clinical trial, the average weight-loss rate with oral Wegovy 25 mg was about 17%, similar to the 2.4 mg injectable.
In particular, patients who avoided or discontinued injections are expected to enter as new demand. He emphasized, "Historically, the ability to raise treatment rates among patient groups that shied away from obesity injections is a significant change."
Shifting to orals also affects pricing and supply strategies. Larsen said, "Price is a key factor that determines patient access," adding, "By lowering prices, millions of patients can begin treatment." He said, "Without expanded manufacturing capacity, price cuts are meaningless," noting that the company proactively bolstered supply capabilities, including the acquisition of Catalent, a contract manufacturer for Wegovy.
U.S. pricing policy is separate from other countries, including Korea. He said, "Drug pricing and reimbursement are decided at the national level," adding, "We adjusted prices after launch in Korea and are discussing various measures with health authorities to improve access."
Novo Nordisk views Korea as a key strategic market in Asia. More than 35 global phase 3 clinical trials, including for obesity and diabetes, are underway in Korea. Larsen said, "Korea has strong medical demand for obesity treatment and excellent clinical research capabilities," adding, "We are pursuing end-to-end innovation across prevention, treatment and management."
He added, "In some countries, after the introduction of GLP-1, indicators show the population-level body mass index (BMI) curve flattening or declining," and "Meaningful changes could also appear in Korea through cooperation with health authorities." The following is a Q&A with Larsen.
– What is your strategy for expanding GLP-1 indications?
"Humanity is still in the early stages of GLP-1 development and expansion. It is important to fully leverage the currently approved indications in obesity, cardiovascular disease, kidney disease, and MASH (metabolic dysfunction–associated steatohepatitis). We recently won approval for MASH in the United States and plan to expand it worldwide. Ozempic's chronic kidney disease protective effect is also a relatively new indication."
– What is the significance of phase 3 trials of semaglutide in Alzheimer's?
"Alzheimer's is extremely challenging for clinical research. Semaglutide showed potential clinical effect, enabling large-scale studies, and we confirmed some biomarker changes and safety. We plan to present more detailed results at this year's Alzheimer's and Parkinson's disease conferences. We will continue exploratory research in CNS disorders."
– What is your strategy for developing amylin analogs (a hormone co-secreted with insulin by the pancreas after meals that gives a sense of satiety in the brain and suppresses glucose production in the liver to control blood-sugar increases)?
"Amylin analogs are an important mechanism that complements GLP-1. In injectables, we can meet patient needs with both monotherapy and combination therapy. Amylin plus GLP-1 offers high weight-loss efficacy, while amylin monotherapy provides a strong safety profile. For some patients, it can be an independent option."
– How does your new drug development speed compare with competitors?
"Speed matters in new drug development, but quality and patient safety come first. We are focusing on timelines while strengthening competitiveness in key phase 3 programs, especially the amylin program. Innovation competition ultimately benefits patients, so we welcome it anytime."
– What differentiates Novo Nordisk in the GLP-1 market?
"Novo Nordisk pioneered the era of GLP-1 therapies and opened the era of oral treatments. We are exploring more than 20 pipeline assets with diverse mechanisms of action and new technologies such as RNA and small molecules. Oral semaglutide demonstrates injectable-level weight-loss efficacy and safety, and the safety evidence based on accumulated prescribing data is a differentiator."
– What are your future M&A and licensing plans, and the potential for partnerships with Korean corporations?
"Focusing on obesity, diabetes and related diseases, we have completed more than 100 transactions since 2020. We seek opportunities worldwide, assess strategic fit with our internal pipeline, and set prices rationally. We are open to technology partnerships and collaborations with Korean corporations, and we have a high regard for Korea's AI and bio technologies."