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) authorised the corporate’s oral model of Wegovy, making it the primary tablet of the favored GLP-1 medicines 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 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.
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The plant, simply exterior of Raleigh, is working across the clock to supply bottles of capsules in 4 completely different doses. The bottles are certain for retail shops and on-line pharmacies and might be out there beginning on Jan. 5. “Weight problems has grow to be a consumer-oriented illness,” mentioned Novo Nordisk’s CEO Mike Doustdar in an interview with TIME. “We’re embracing that.”
The corporate’s total provide of the drug, from begin to end, might 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 supply 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 supply semaglutide, a compound that mimics a human hormone that regulates urge for food by working within the reward heart of the mind. It will possibly assist folks really feel full and cut back emotions of starvation.
Harvesting the principle ingredient
After the fermentation and purification course of, semaglutide types a beige paste with the consistency of pancake batter. In one of many few handbook 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 tablet, the corporate at the moment has a couple of month’s provide of semaglutide in its freezers.
Taking tablet type
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, much like the best way snow-making machines flip scorching water into snow. That powder, collected in massive luggage from a funnel that extends by way of three flooring, is then pressed into Wegovy tablets.
An extended 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 inquisitive about semaglutide as a diabetes therapy since it may well additionally assist management blood glucose, and its first semaglutide-based remedy, Ozempic, was authorised 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 type, referred to as Rybelsus, which the FDA authorised in 2019. Turning Ozempic into an oral tablet required discovering a option to defend the drug from the hostile surroundings of the abdomen simply lengthy sufficient for it to be absorbed by the physique. “However with a number of these methods, it might 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 option to create a chemical buffer to defend 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 typically not as efficient because the injected Ozempic.
When diabetes sufferers seen 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 authorised Novo Nordisk’s Wegovy to deal with weight problems. However folks nonetheless needed to inject themselves with the treatment to learn from its results. Creating 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 higher navigate the troublesome surroundings 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 briefly 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 era “the microenvironment of the abdomen goes again to regular.” To maximise the tablet’s skill to soak up, folks 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 tablet’s exercise.
Stiff competitors
Wegovy tablet just isn’t the one GLP-1 weight-loss tablet on the horizon. Eli Lilly, which makes the injectable GLP-1 medication 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 might assist folks keep 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, that means the FDA will conduct an expedited overview in order that tablet can come to market a lot sooner 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 larger 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 larger than that of semaglutide in Wegovy. For that cause, Novo Nordisk is growing the next dose of Wegovy within the injectable type that produces comparable quantities of about 20% weight reduction. “We might 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 supply plenty of well being advantages. It’s the one GLP-1 drug that the FDA permits to say on its label advantages forthat coronary heart illness and sure liver situations profit. Whereas current analysis discovered that the compound didn’t gradual Alzheimer’s illness, as many had hoped it might, the drug’s skill to cut back irritation might result in extra well being advantages in different metabolic ailments.
Doustdar, who was appointed to move Novo Nordisk final summer time as the corporate started shedding market share within the GLP-1 area to Eli Lilly, sees Wegovy tablet as a coup for the corporate—and a return to specializing in diabetes and weight problems. “It is a huge illness space. We’re speaking about two billion folks, and finally, somebody has to supply 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 might be out there 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 step by step ramp up their dosage over a interval of months till they attain the utmost dose, which they are going to proceed to take care of their new weight.
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