© Reuters. FILE PHOTO: Flags are seen outside the headquarters of Novo Nordisk in Copenhagen, Denmark, February 5, 2020. REUTERS/Jakob Grunholt Pedersen/File Photo
Written by Dina Beasley
SAN DIEGO (Reuters) – Novo Nordisk said Sunday that a late-stage trial found that an oral high-dose of the drug semaglutide helped adults who were overweight or obese lose 15% of their body weight, which is in line with recent results for others. Experimental obesity pills.
Novo plans to seek approval from US and European regulators for the high-dose pill later this year, but the timing of its market launch “will be determined,” according to Mikko Guevara, MD, medical director at Novo Nordisk (NYSE:NYSE).
The Danish company has run into supply problems and is struggling to keep up with growing US demand for Wegovy and Ozempic, the respective brand names for semaglutide sold as weekly injections to treat obesity and diabetes. Wegovy contains 2.4mg of semaglutide.
The drug, which is designed to activate hormones that regulate blood sugar, slow stomach emptying and reduce appetite, is part of a new class that has reignited researchers and investors’ interest in the weight-loss treatment market, which is estimated to reach $100 billion by the end of the decade.
“We’re increasing production as much as we can,” Guevara said in an interview here on the sidelines of the American Diabetes Association’s annual meeting.
Novo Nordisk already markets oral semaglutide, under the brand name Rybelsus, for the treatment of type 2 diabetes, but its highest dose is 14 mg.
A late-stage trial of 667 obese and overweight adults tested the 50 mg dose, and showed that it resulted in an average weight loss of 15.1% after 68 weeks, when used along with diet and physical activity, compared to 2.4% for the placebo group. .
Oral semaglutide, according to the FDA label, should be taken in the morning on an empty stomach, 30 minutes before eating, drinking, or using any other oral medication — you are only allowed 4 ounces of plain water. If you eat too early, the pill is less effective, but if you wait longer than 30 minutes, its absorption may be enhanced.
Other companies are working on obesity pills that don’t have such dietary restrictions, and would theoretically also appeal to patients who don’t want to inject themselves weekly.
Dr Philipp Knopf, professor of endocrinology at Gentofte Hospital, University of Copenhagen and presenter of the Novo study, said his experience is that 20% to 25% of patients would prefer to take a daily pill rather than a weekly semaglutide injection.
At the ADA meeting on Friday, results from the Eli Lilly (NYSE::) mid-stage trial showed that the highest dose of the experimental birth control pill, or Forglipron, helped people who were obese or overweight lose 14.7% of their body weight after 36 weeks. Weight loss has not yet reached a plateau.
Novo Nordisk said most patients in its obesity trial reported gastrointestinal side effects from oral semaglutide, including mild to moderate nausea, constipation, diarrhea, and vomiting.
About 13 percent of patients experienced a “change in skin sensation,” Dr. Knopf said, which mostly resolved after several weeks.
Results of a separate, late-stage trial presented at the ADA meeting showed that oral semglutide once daily, at a dose of up to 50 mg, helped patients with type 2 diabetes lower blood sugar levels by up to 2 percentage points.
Details of the two de novo trials have also been published in the peer-reviewed medical journal The Lancet.