Tuesday, May 3, 2022

Novo Nordisk, after obesity trial win for injectable semaglutide, plans test for oral version

Fresh off of presenting eye-popping data for its obesity drug candidate semaglutide, Novo Nordisk is upping the ante with a more user-friendly version of the treatment.

The company is set to test an oral version of the drug, a potentially attractive alternative to the once-a-week subcutaneous injection that aced a late-stage trial.

The phase 3a program will enroll about 1,000 overweight participants and will examine the efficacy and safety of the oral treatment versus placebo. The study will kick off in the second half of this year.

Marketed as Ozempic, semaglutide is already in widespread use as a treatment for Type 2 diabetes. But the Danish company hopes to tap a much larger market as a treatment for obesity. Oral semaglutide is approved in Type 2 diabetes as Rybelsus.

“There is significant unmet medical need with obesity treatment today,” Novo’s executive VP of development Martin Holst Lange said in a statement. “With oral semaglutide we aim to introduce a convenient and effective treatment option.”

RELATED: Novo Nordisk makes headway in bid to rule obesity market with stunning phase 3 semaglutide data

Meanwhile, the injected version of semaglutide is already under regulatory review for obesity in the United States and Europe. Novo Nordisk expects a ruling from the FDA in the middle of this year, with Europe to follow in 2022.

The drug, an analog of the human glucagon-like peptide-1 hormone, induces weight loss by reducing hunger and increasing the feeling of fullness.  

In February, Novo Nordisk released impressive results of a phase 3 trial of 1,961 adults who received a weekly 2.4 mg dose by self-injection. A third of patients lost more than 20% of their body weight over a 68-week period, with the average participant dropping 33 pounds, investigators found. In addition, many saw improvements in their risk factors for diabetes and heart disease.

The results were a “game-changer,” study co-author Rachel Batterham of University College at London said at the time. Other experts were more reserved, noting that the drug causes gastrointestinal issues and that all studies of obesity drugs need to be considered over a longer period of time to determine true efficacy. 

Shortly after Novo’s semaglutide posted those impressive data, Eli Lilly’s dual-action candidate tirzepatide out-performed the Novo medicine in reducing blood sugar levels and body weight in diabetes patients. In all, the data set the scene for a potentially interesting competition between Novo Nordisk and Lilly as they vie for diabetes patients and as Novo eyes separate obesity indications for its medicines. 

RELATED: Lilly has its Ozempic-beating data from a head-to-head diabetes trial. Should Novo Nordisk be worried?

Novo also markets a weight-loss shot Saxenda, a version of its older GLP-1 diabetes drug Victoza. That obesity medicine generated about $900 million in sales last year.

Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...