FDA Approves Novo Nordisk's Oral Semaglutide, First GLP-1 in Pill Form on Sept. 20th. As a long-acting GLP-1 analog, semaglutide has a mechanism of action similar to GLP-1. And GLP-1 is a peptide hormone secreted by intestinal L cells, which, after specifically binding to the receptor, mainly gives play to the secretion of blood glucose-dependent incretin via the cyclic AMP signaling pathway. According to research, semaglutide could not only largely improve blood glucose of patients with type 2 diabetes but also decrease appetite and reduce food intake and induce weight loss. Besides, it could significantly reduce the risks of MACE of patients with type 2 diabetes. Semaglutide subcutaneous injection was approved by the FDA in Dec. 2017 to treat type 2 diabetes, with the trade name of Ozempic and 2018 sales reaching USD284 million.
Semaglutide subcutaneous injection has the same main ingredient as semaglutide tablets, with the only difference being that semaglutide tablets uses sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC) as the excipient and its safety and effectiveness have been proved in the PIONEER trials. Besides the difference in the administration method, those two dosage forms also have different administration frequencies, with the injection administered once weekly while tablets administered once daily. If semaglutide tablets is smoothly approved, it will have inestimable business prospects. The pharmaceutical market research institution EvaluatePharma predicts that semaglutide’s sales in 2024 will reach USD1.994 billion.
With the Approval of World’s First Oral GLP-1 Receptor Agonist, Novo Nordisk Maintains its Dominance in the Diabetes Area
"When brothers come together, there is nothing they cannot achieve."
Novo Nordisk, when the competitive edge of its pillar product—insulin became less obvious, has locked on the GLP-1 receptor agonist area and launched Victoza (liraglutide) in 2010. Since marketed, Victoza’s sales have grown fast year by year (as shown in the following table) and it has rapidly become a pillar of Novo Nordisk in the diabetes area.
However, with other GLP-1 receptor agonists approved for marketing, we can see from the above table that Victoza’s growth was clearly not as good as previous years and its proportion in the GLP-1 market declined year by year. With the advantage of Novo Nordisk in the GLP-1 area of diabetes drugs whittled away, semaglutide developed in 2017 is expected to win a round for it, because according to the head-to-head SUSTAIN clinical trial data, semaglutide was significantly better than dulaglutide, sitagliptin, insulin glargine, or exenatide extended-release in terms of reducing blood glucose and losing weight and semaglutide was proved to provide cardiovascular benefits. This study has established the dominance of semaglutide among GLP-1 receptor agonists. Novo Nordisk is predicted to rapidly seize the share in the diabetes drug market in the diabetes area with the marketing of semaglutide and the approval of the new dosage form.
The increasingly white-hot competition of GLP-1 receptor agonists
So far, there have been 7 GLP-1 receptor agonists approved by the FDA, separately, Novo Nordisk’s liraglutide and semaglutide, AstraZeneca’s exenatide and its extended-release, Eli Lilly’s dulaglutide, Sanofi’s lixisenatide, and GSK’s albiglutide (see the following table for details). Exenatide analogs and human GLP-1 analogs are currently the two major categories in GLP-1 receptor agonist R&D, wherein, exenatide is a GLP-1 analog separated from lizard saliva, bearing a 53% homology to human GLP-1 and having a longer half-life and stronger bioactivity because its second amino acid residue, alanine, in N-terminal region is replaced by glycine not decomposed by human dipeptidyl peptidase IV (DPP-1V). Lixisenatide and albiglutide are exenatide analogs, while liraglutide, dulaglutide, and semaglutide are human GLP-1 analogs of which the immunogenicity is lower than that of exenatide and its analogs because human GLP-1 has a higher homology.
The above 7 GLP-1 receptor agonists approved also have different actio...
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