Novo Nordisk broadens U.S. patient access to FDA-approved semaglutide treatments through Hims & Hers following a strategic shift in its U.S. GLP-1 business approach.
Novo Nordisk today announced it has reached an agreement with telehealth company Hims & Hers that will take effect later this month. Under the terms of the agreement, Hims & Hers will offer access to FDA-approved Ozempic® (semaglutide) injection 0.5 mg, 1 mg, and 2 mg and Wegovy® (semaglutide) tablets 1.5 mg, 4 mg, 9 mg, and 25 mg and injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg, to US consumers at the same affordable self-pay prices as other telehealth platforms.
We welcome Hims & Hers shifting their GLP-1 business model to focus on increasing access to affordable, branded FDA-approved medicines. Hims & Hers will no longer advertise compounded GLP-1 offerings on its platform or in its marketing, and existing patients will have the opportunity to transition to FDA-approved alternatives when clinically appropriate in consultation with a healthcare professional.
“This agreement with Hims & Hers is a meaningful win for patients in the United States. By expanding access through leading telehealth providers and digital care platforms, we are helping to connect more people with our FDA-approved medicines, which have been evaluated for safety and efficacy,” said Mike Doustdar, President and CEO of Novo Nordisk. “Wegovy® is not simply an obesity therapy.
It is a clinically proven treatment that helps adults with obesity lose weight while also reducing the risk of cardiovascular events in patients who also have heart disease. That combination of powerful weight loss efficacy and proven risk reduction is what makes Wegovy® truly distinct. We all want better health. Our goal is simple: ensure that every patient who can benefit from our medicines has the opportunity to access them, wherever they choose to receive care.”
Patients using Hims & Hers will soon have access to the full range of FDA-approved semaglutide medicines, including the Wegovy® pill which delivers a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials. All doses of Ozempic® (injectable) and Wegovy® (injectable and pill) are broadly available nationwide for Americans across 70,000+ pharmacies, our own direct-to-consumer platform, NovoCare® Pharmacy, and select telehealth providers and digital platforms.
In OASIS 4, Wegovy® pill demonstrated an average weight loss of about 17% (16.6%), when used along with a reduced-calorie diet and exercise and if all patients stayed on treatment, compared to about 3% (2.7%) for placebo.*1Novo Nordisk When looking at the efficacy regardless of if all patients stayed on treatment, an average weight loss of about 14% (13.6%) was achieved by people taking Wegovy® pill compared to about 2% (2.4%) for placebo.**1 Common adverse reactions were similar to those previously seen in clinical trials with Wegovy® (semaglutide) injection 2.4 mg, including nausea, diarrhea, and vomiting.1
Along with diet and exercise, Wegovy® pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke in adults with overweight or obesity and established cardiovascular disease.
Ozempic® is approved for adults with type 2 diabetes along with diet and exercise to improve blood sugar control and to reduce the risk of MACE such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.
In light of this agreement, Novo Nordisk is dismissing our patent infringement lawsuit against Hims & Hers while reserving the right to refile in the future.
OASIS 4 was a 64-week phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with one or more weight-related comorbidities.1 People with diabetes were excluded.1 OASIS 4 included a 64-week treatment period, including a 12-week dose escalation, and a 7-week off-treatment follow-up period.
In total, 307 participants were randomized in a 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, alongside lifestyle intervention for 64 weeks.
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