Within the final week of December, whereas a lot 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) accepted the corporate’s oral model of Wegovy, making it the primary capsule of the favored GLP-1 medicines to get the inexperienced gentle for weight reduction. Individuals who wish to shed pounds and are prescribed Wegovy now have the choice of taking the pill each 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 outdoors of Raleigh, is working across the clock to provide bottles of capsules in 4 completely different doses. The bottles are certain for retail shops and on-line pharmacies and can be accessible beginning on Jan. 5. “Weight problems has develop into a consumer-oriented illness,” stated Novo Nordisk’s CEO Mike Doustdar in an interview with TIME. “We’re embracing that.”
The corporate’s whole provide of the drug, from begin to end, can be manufactured in North Carolina. Days earlier than the launch of Wegovy capsule, TIME visited the plant to look at how the primary Wegovy capsules are being produced, bottled, and packaged for sufferers.
All of it begins with yeast
Wegovy capsule begins with a fungus: particularly, the identical yeast used to make bread, known 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 could assist individuals really feel full and cut back emotions of starvation.
Harvesting the primary ingredient
After the fermentation and purification course of, semaglutide varieties 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 massive 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 capsule, the corporate presently has a couple of month’s provide of semaglutide in its freezers.
Taking capsule kind
Within the last 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 tremendous white powder, just like the best way snow-making machines flip sizzling water into snow. That powder, collected in massive luggage from a funnel that extends by means of three flooring, is then pressed into Wegovy tablets.
An extended path to the capsule
Whereas this semaglutide capsule 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 all in favour of semaglutide as a diabetes remedy since it might additionally assist management blood glucose, and its first semaglutide-based remedy, Ozempic, was accepted 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 capsule kind, known as Rybelsus, which the FDA accepted in 2019. Turning Ozempic into an oral capsule required discovering a technique to shield the drug from the hostile atmosphere of the abdomen simply lengthy sufficient for it to be absorbed by the physique. “However with loads of these methods, it will 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 in the end discovered a technique to create a chemical buffer to defend the drug whereas it launched sufficient semaglutide to be efficient. Nonetheless, as a result of the capsule has to undergo the abdomen and digestive tract, it’s typically not as efficient because the injected Ozempic.
When diabetes sufferers observed they have been shedding weight on semaglutide, Novo Nordisk and different corporations 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 accepted 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 capsule grew to become the subsequent problem, and the identical hurdles the corporate confronted in creating Rybelsus remained. However this time, the researchers developed a proprietary fatty acid by-product to higher navigate the tough 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 capsule,” 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 supplies 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 capsule’s skill 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 medicines for at the very least half-hour, the corporate advises, so nothing will intervene with the capsule’s exercise.
Stiff competitors
Wegovy capsule will not be the one GLP-1 weight-loss capsule on the horizon. Eli Lilly, which makes the injectable GLP-1 medication Mounjaro for diabetes and Zepbound for weight reduction (utilizing the lively ingredient tirzepatide) has developed a capsule known as orforglipron. In December, the corporate launched constructive knowledge displaying its capsule may assist individuals preserve weight reduction after utilizing injected types of GLP-1 medication for greater than a yr and submitted a request to the FDA for approval. The company granted orforglipron a precedence voucher in November, which means the FDA will conduct an expedited overview in order that capsule can come to market a lot quicker than the everyday 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 better weight reduction—as much as 21% of physique weight—in comparison with 15% on Wegovy. “The distinction could be very largely linked to doses,” says Doustdar; the best dose tirzepatide is bigger than that of semaglutide in Wegovy. For that purpose, Novo Nordisk is creating the next dose of Wegovy within the injectable kind that produces comparable quantities of about 20% weight reduction. “We can be bringing Wegovy-Plus into the market [in 2026] so it should shut the hole with our competitor,” he says.
He additionally sees semaglutide as the corporate’s “secret sauce” that appears to provide a lot 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 circumstances profit. Whereas latest analysis discovered that the compound didn’t sluggish Alzheimer’s illness, as many had hoped it will, the drug’s skill to scale back irritation may result in further well being advantages in different metabolic ailments.
Doustdar, who was appointed to move Novo Nordisk final summer season as the corporate started shedding market share within the GLP-1 house to Eli Lilly, sees Wegovy capsule as a coup for the corporate—and a return to specializing in diabetes and weight problems. “This can be a massive illness space. We’re speaking about two billion individuals, and finally, somebody has to provide all of the doses for them. We’re sitting in the suitable spot proper now [to do that], and nonetheless solely touching a fraction of the people who find themselves in want.”
Choices for the capsule
In coming weeks, Wegovy capsule can 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 steadily ramp up their dosage over a interval of months till they attain the utmost dose, which they may proceed to take care of their new weight.
As the corporate and the White Home introduced in November, the starter dose will value $149 for a month’s provide for individuals paying out-of-pocket and utilizing federal insurance coverage. The subsequent-highest dose can be $149 till April 2026, after which it should enhance to $199 a month. The 2 highest doses will value $299 for a month’s value of capsules. Individuals with insurance coverage that cowl the capsules could 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 value plan for the drug. “For us to have the ability to make any offers, it has to not be a zero-sum sport, however a win-win scenario,” he says. “We wanted to elucidate that the price of operations within the U.S. could be very completely different from the price of operations in Europe.”
“Alternatively, we additionally acknowledge that at greater costs, we won’t get entry to greater volumes,” he says—and with tons of of thousands and thousands of individuals world wide who may probably profit from a weight-loss drug, Doustdar hopes Wegovy capsule can be extra handy, and accessible, for them.
