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Flags with the logos of Danish drugmaker Novo Nordisk, maker of the blockbuster diabetes and weight-loss therapies Ozempic and Wegovy are photos whereas the corporate presents the annual report at Novo Nordisk in Bagsvaerd, Denmark, on February 5, 2025.
Mads Claus Rasmussen | Afp | Getty Photographs
Novo Nordisk mentioned Wednesday that late-stage trial outcomes for its once-daily weight problems capsule confirmed “vital” weight discount and tolerability consistent with its blockbuster Wegovy injection, as drugmakers race to get an oral therapy to market.
Outcomes from the part 3 Oasis 4 trial confirmed the oral semaglutide capsule led to common weight discount of 16.6% after 64 weeks in sufferers with weight problems or obese and at the least one weight-related comorbidity, the Danish pharmaceutical agency mentioned.
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Dubbed the “Wegovy capsule,” Novo Nordisk’s Chief Science Officer Martin Holst Lange instructed CNBC that the oral therapy provided sufferers an essential various to its present once-weekly injection.
“Our job was to indicate that, with the pill, we may get the identical efficacy and the identical security and tolerability as we are able to with the injectable. That we’ve got now achieved,” Lange mentioned by cellphone.
“That principally signifies that we are able to supply sufferers the selection between the pill and the injectable, and that may make a distinction for some sufferers,” he added.
Novo Nordisk’s oral therapy depends on the identical Semaglutide GLP-1 remedy that underpins the corporate’s present weight problems and diabetes therapies, Wegovy and Ozempic. Wegovy was proven to cut back weight by 15% on common in sufferers with obese or weight problems and at the least one weight-related comorbidity in an earlier Novo research.
The capsule is presently beneath evaluate with the U.S. Meals and Drug Administration, having been submitted beneath a New Drug Software in February. A choice is due within the fourth quarter of this 12 months.
If accepted, the corporate mentioned the capsule might be made totally within the U.S. It comes as world pharma corporations have been ramping up their U.S. investments amid strain from the Trump administration to bolster home manufacturing.
The weight problems capsule race
There are presently no accepted oral variations of GLP-1s in the marketplace, nonetheless competitors is shortly heating up. Tablet therapies are thought-about a key milestone for corporations searching for to make the medication extra accessible, together with to these with an aversion to needles.
Analysts instructed Reuters Tuesday that rival Eli Lilly‘s competitor weight problems capsule, Orforglipron, might be fast-tracked for approval inside one to 2 months beneath the FDA’s “Commissioner’s Nationwide Precedence Voucher” — a brand new initiative to additional the Trump administration’s drug improvement targets.
Lange mentioned Novo welcomes “good competitors” however added it was centered on drug outcomes, together with long-term adoption charges.
“On this scenario, we have a look at the information,” Lange mentioned. “Semaglutide as a pill has the potential to supply 17% physique weight reduction and with a superb security and tolerability profile.”
“What we have seen from our competitor is barely greater than 12% weight reduction. And, once more, we won’t do direct comparisons, however at the least we are able to see a discontinuation fee, suggesting that possibly Semaglutide additionally has a [more] efficient security and tolerability profile.”
In a part 3 ATTAIN-1 trial launched Tuesday, Eli Lilly mentioned Orforglipron resulted in common weight lack of 12.4% on the highest dose after 72 weeks in adults with weight problems, or obese with at the least one comorbidity.
However, the U.S. drug maker mentioned Wednesday that its capsule outperformed Novo’s within the first head-to-head research evaluating the 2 medicines’ efficacy in decreasing blood sugar ranges in sufferers with Sort 2 diabetes.
Each corporations have been experimenting with new so-called next-generation medication, with Novo on Tuesday flagging promise in its Cagrilintide long-acting amylin analogue — a nascent type of weight reduction therapy.
It comes because the Danish firm final week introduced plans to chop round 9,000 roles as a part of a wider shake-up beneath new CEO Mike Doustdar, who has vowed to reset the corporate after a interval of weaker progress.
“What we’re doing now’s specializing in our core, which is diabetes and weight problems. That may embody steady funding in each diabetes and weight problems, and in addition, as we mentioned, the associated comorbidities,” Lange mentioned Wednesday.
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