Novo Nordisk has FDA approval for the first oral alternative to injectable GLP-1 agonists, which the company thinks could be a blockbuster product.
The US regulator has approved the Danish drugmaker’s oral formulation of semaglutide under the Rybelsus brand name, extending its range of GLP-1 agonist drugs that include once-weekly injectable Ozempic – also based on semaglutide – and once-daily shot Victoza (liraglutide).
Novo Nordisk has a lot riding on the new drug, so much so that it used a coveted priority review voucher to speed up the FDA’s review and bring it to market as quickly as possible.
The company’s diabetes franchise has been hit by competition to its GLP-1 drugs from rivals like Eli Lilly’s fast-growing Trulicity (dulaglutide), as well as downwards pressure on pricing in the US from payers.
Sales of Victoza fell 5% in the first half of the year to around $1.6bn, and while the decline was more than offset by growth by Ozempic’s $550m contribution the company’s market share is being squeezed as Lilly’s drug looks set to top the $4bn threshold this year.
Rybelsus will be launched in the US in the fourth quarter, but for now Novo Nordisk isn’t revealing its pricing plans for the product other than to say it will be “competitive” with other GLP-1 agonist drugs. It was filed for approval in Europe in April.
Analysts at Pareto Securities have suggested that demand for an oral alternative could make Rybelsus a $5.4bn product at peak, according to Reuters, and that would make it a larger product than Victoza at its peak.
“Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible,” said Lisa Yanoff, the FDA’s acting head of metabolism and endocrinology products.
The agency “welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition”, she added.
The convenience of a daily pill is also accompanied by data showing that it outperformed other drugs for type 2 diabetes.
In the Pioneer programme, people treated with oral semaglutide achieved greater blood glucose reductions compared to Merck & Co’s DPP-4 inhibitor Januvia (sitagliptin), Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor Jardiance (empagliflozin) and Victoza, as well as placebo.
Novo Nordisk has also reported results from a head-to-head trial with Trulicity which suggested oral dosing was superior for controlling blood glucose control and achieving weight loss.
The company has also filed a second marketing application in the US seeking approval for a cardiovascular risk reduction indication in adults with type 2 diabetes, but won’t get a verdict on that until next year.
Lilly is also angling for a cardiovascular outcomes claim for Trulicity based on the REWIND study data, with an FDA decision on that also due in 2020.