Within the final week of December, whereas many of the U.S. was nonetheless in vacation mode, Novo Nordisk’s plant in North Carolina was working at full capability.
On Dec. 22, the U.S. Meals and Drug Administration (FDA) permitted the corporate’s oral model of Wegovy, making it the primary tablet of the favored GLP-1 drugs to get the inexperienced gentle for weight reduction. Individuals who wish to drop some pounds and are prescribed Wegovy now have the choice of taking the pill day by day, versus injecting themselves with the drug as soon as every week. They’ll lose about the identical quantity of weight with both model: between 16% and 17% of their beginning physique weight.
The plant, simply exterior of Raleigh, is working across the clock to provide bottles of capsules in 4 completely different doses. The bottles are sure for retail shops and on-line pharmacies and shall be accessible beginning on Jan. 5. “Weight problems has turn into a consumer-oriented illness,” mentioned Novo Nordisk’s CEO Mike Doustdar in an interview with TIME. “We’re embracing that.”
The corporate’s complete provide of the drug, from begin to end, shall be manufactured in North Carolina. Days earlier than the launch of Wegovy tablet, TIME visited the plant to observe how the primary Wegovy capsules are being produced, bottled, and packaged for sufferers.
All of it begins with yeast
Wegovy tablet begins with a fungus: particularly, the identical yeast used to make bread, referred to as Saccharomyces cerevisiae. However as an alternative of fermenting sugars or grains to make bread rise, the yeast cells are genetically engineered at Novo Nordisk’s facility in Clayton, North Carolina to provide a protein that undergoes fermentation in a number of four-story tall tanks, then a number of purification steps over a couple of month to provide semaglutide, a compound that mimics a human hormone that regulates urge for food by working within the reward middle of the mind. It will possibly assist individuals really feel full and cut back emotions of starvation.
Harvesting the primary ingredient
After the fermentation and purification course of, semaglutide kinds a beige paste with the consistency of pancake batter. In one of many few guide steps within the largely automated manufacturing, technicians scrape the paste from giant funnels and freeze it at -20°C, the place it retains for as much as 5 years. However given the recognition of Wegovy and the anticipated demand for the tablet, the corporate at the moment has a couple of month’s provide of semaglutide in its freezers.
Taking tablet kind
Within the closing step of the method, the paste is thawed and purified right into a liquid at a excessive temperature. That heated liquid is then spray-dried right into a positive white powder, much like the way in which snow-making machines flip sizzling water into snow. That powder, collected in giant baggage from a funnel that extends via three flooring, is then pressed into Wegovy tablets.
A protracted path to the tablet
Whereas this semaglutide tablet is the primary to deal with weight problems, it isn’t the primary that Novo Nordisk has made. The corporate’s scientists first grew to become desirous about semaglutide as a diabetes remedy since it will possibly additionally assist management blood glucose, and its first semaglutide-based remedy, Ozempic, was permitted in 2017 for diabetes. Sufferers injected themselves as soon as every week to manage blood sugar, however to make taking the drug simpler, the corporate additionally developed a tablet kind, referred to as Rybelsus, which the FDA permitted in 2019. Turning Ozempic into an oral tablet required discovering a option to shield the drug from the hostile atmosphere of the abdomen simply lengthy sufficient for it to be absorbed by the physique. “However with a number of these methods, it could trigger an excessive amount of permeability—so issues that shouldn’t be absorbed, like micro organism or different issues, have been absorbed,” says Andrea Traina, senior medical director for weight problems and liver well being at Novo Nordisk. The scientists finally discovered a option to create a chemical buffer to protect the drug whereas it launched sufficient semaglutide to be efficient. Nonetheless, as a result of the tablet has to undergo the abdomen and digestive tract, it’s usually not as efficient because the injected Ozempic.
When diabetes sufferers observed they have been losing a few pounds on semaglutide, Novo Nordisk and different firms started to review the compound for its potential results on weight problems. Research confirmed what these sufferers have been experiencing, and in 2021, the FDA permitted Novo Nordisk’s Wegovy to deal with weight problems. However individuals nonetheless needed to inject themselves with the remedy to learn from its results. Growing the Wegovy tablet grew to become the subsequent problem, and the identical hurdles the corporate confronted in growing Rybelsus remained. However this time, the researchers developed a proprietary fatty acid by-product to raised navigate the troublesome atmosphere of the abdomen. “After you swallow the pill, it is available in contact with the abdomen lining and begins to dissolve and create a foamy microenvironment across the tablet,” says Traina. “Image an Alka-Seltzer pill dissolving in water.” The response quickly inhibits abdomen enzymes within the space from breaking down the drug, which provides the semaglutide sufficient time to be absorbed. “The entire course of takes about half an hour,” she says, after which period “the microenvironment of the abdomen goes again to regular.” To maximise the tablet’s capacity to soak up, individuals taking it ought to swallow it very first thing within the morning on an empty abdomen with as much as half a glass of water with no meals, drinks, or different drugs for at the very least half-hour, the corporate advises, so nothing will intervene with the tablet’s exercise.
Stiff competitors
Wegovy tablet will not be the one GLP-1 weight-loss tablet on the horizon. Eli Lilly, which makes the injectable GLP-1 medicine Mounjaro for diabetes and Zepbound for weight reduction (utilizing the energetic ingredient tirzepatide) has developed a tablet referred to as orforglipron. In December, the corporate launched optimistic information exhibiting its tablet may assist individuals keep weight reduction after utilizing injected types of GLP-1 medicine for greater than a 12 months and submitted a request to the FDA for approval. The company granted orforglipron a precedence voucher in November, that means the FDA will conduct an expedited assessment in order that tablet can come to market a lot sooner than the standard drug.
Novo Nordisk and Eli Lilly have been locked in a GLP-1 competitors for years. Some analysis has discovered that Lilly’s drug Zepbound results in larger weight reduction—as much as 21% of physique weight—in comparison with 15% on Wegovy. “The distinction may be very largely linked to doses,” says Doustdar; the best dose tirzepatide is larger than that of semaglutide in Wegovy. For that cause, Novo Nordisk is growing the next dose of Wegovy within the injectable kind that produces comparable quantities of about 20% weight reduction. “We shall be bringing Wegovy-Plus into the market [in 2026] so it is going to shut the hole with our competitor,” he says.
He additionally sees semaglutide as the corporate’s “secret sauce” that appears to provide plenty of well being advantages. It’s the one GLP-1 drug that the FDA permits to assert on its label advantages forthat coronary heart illness and sure liver situations profit. Whereas current analysis discovered that the compound didn’t sluggish Alzheimer’s illness, as many had hoped it could, the drug’s capacity to cut back irritation may result in extra well being advantages in different metabolic ailments.
Doustdar, who was appointed to go Novo Nordisk final summer season as the corporate started shedding market share within the GLP-1 house to Eli Lilly, sees Wegovy tablet as a coup for the corporate—and a return to specializing in diabetes and weight problems. “This can be a large illness space. We’re speaking about two billion individuals, and ultimately, somebody has to provide all of the doses for them. We’re sitting in the correct spot proper now [to do that], and nonetheless solely touching a fraction of the people who find themselves in want.”
Choices for the tablet
In coming weeks, Wegovy tablet shall be accessible in 4 doses: a starter dose of 1.5 mg, in addition to 4 mg, 9 mg, and 25 mg. As with injectable Wegovy, most sufferers will begin with the bottom dose and regularly ramp up their dosage over a interval of months till they attain the utmost dose, which they may proceed to keep up their new weight.
As the corporate and the White Home introduced in November, the starter dose will price $149 for a month’s provide for individuals paying out-of-pocket and utilizing federal insurance coverage. The following-highest dose shall be $149 till April 2026, after which it is going to enhance to $199 a month. The 2 highest doses will price $299 for a month’s price of capsules. Individuals with insurance coverage that cowl the capsules might pay as little as $24 for a 30-day provide.
Doustdar says the White Home announcement was the results of a number of months of dialogue to succeed in a mutually agreeable worth plan for the drug. “For us to have the ability to make any offers, it has to not be a zero-sum recreation, however a win-win scenario,” he says. “We wanted to clarify that the price of operations within the U.S. may be very completely different from the price of operations in Europe.”
“Alternatively, we additionally acknowledge that at greater costs, we is not going to get entry to larger volumes,” he says—and with lots of of thousands and thousands of individuals around the globe who may probably profit from a weight-loss drug, Doustdar hopes Wegovy tablet shall be extra handy, and accessible, for them.
