Novo Nordisk says obesity pill leads to 15% weight loss; availability “to be determined” By Reuters

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<span>© Reuters. FILE PHOTO: Flags are seen outside Novo Nordisk headquarters in Copenhagen, Denmark, February 5, 2020. REUTERS/Jacob Gronholt-Pedersen/File Photo</span><br />
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<p>By Deena Beasley</p>
<p>SAN DIEGO (Reuters) – Drugmaker Novo Nordisk (NYSE:) on Sunday said a late-stage trial found that a high-dose oral version of its drug semaglutide helped overweight or obese adults lose 15% of their body weight, which is in line with recent results for other experimental obesity pills.</p>
<p>Novo plans to seek U.S. Food and Drug Administration approval of the high-dose pill later this year, but timing of a market launch is “to be determined,” according to Mico Guevarra, medical director at Novo Nordisk.</p>
<p>The Danish company has had supply issues and struggled to keep up with soaring U.S. demand for Wegovy and Ozempic, the respective brand names for semaglutide sold as once-weekly injections for treating obesity and diabetes.</p>
<p>The drug, designed to activate hormones that regulate blood sugar, slow stomach emptying and decrease appetite, is part of a new class that has reignited researcher and investor interest in the weight-loss treatment market, which is estimated to reach $100 billion by the end of the decade. </p>
<p>“We are upping production as much as we can,” Guevarra said in an interview here on the sidelines of the annual meeting of the American Diabetes Association.</p>
<p>Novo Nordisk already markets an oral semaglutide, under the brand name Rybelsus, for treatment of type 2 diabetes, but its highest dose is 14mg.</p>
<p>The Phase 3 trial of 667 obese and overweight adults tested a dose of 50mg, showing that it resulted in average weight loss of 15.1% after 68 weeks, when used alongside diet and physical activity, compared with 2.4% for the placebo group.</p>
<p>Oral semaglutide, according to the FDA label, needs to be taken in the morning on an empty stomach, 30 minutes before eating, drinking, or using any other oral medication – you are allowed only 4 ounces of plain water. If you eat too soon, the pill is less effective, but if you wait longer than 30 minutes its absorption may be enhanced.</p>
<p>Other companies are working on obesity pills that don’t have such dietary restrictions, and would in theory also appeal to patients who don’t want to inject themselves weekly.</p>
<p>At the ADA meeting on Friday, results from an Eli Lilly (NYSE:) mid-stage trial showed that the highest dose of its experimental pill orforglipron helped people who were obese or overweight lose 14.7% of their body weight after 36 weeks, and their weight loss had not yet appeared to plateau.</p>
<p>Novo Nordisk said most patients in its obesity trial reported gastrointestinal side effects from oral semaglutide, including mostly mild-to-moderate nausea, constipation, diarrhea and vomiting.</p>
<p>Results from a separate Phase 3 trial presented at the ADA meeting showed once-daily oral semglutide, at a dose of up to 50mg, helped patients with type 2 diabetes reduce their blood sugar levels by as much as 2 percentage points.</p>
<p>Details of both Novo trials were also published in the peer-reviewed Lancet medical journal. </p>
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