$26 / day! Novo Nordisk announces that the price of oral somalutide is equivalent to that of similar injection products

On September 20, rybelsus (semaglutide, somalutide tablet) of Novo Nordisk was approved by the US FDA Combined with diet control and exercise, it can improve the blood glucose control of adult patients with type 2 diabetes The drug is the first approved oral glucagon like peptide-1 (GLP-1) receptor agonist drug in the world It is taken orally once a day The approved therapeutic doses are 7Mg and 14mg It will be launched in the United States in the fourth quarter Recently, Novo Nordisk disclosed the price of rybelsus - $26 / day for all specifications (7Mg, 14mg), or $772 / 30 tablets, which is equivalent to the price of similar injection products The disclosure ended a two-year debate over the price of the oral version of semaglutide and "dispelled investor concerns that Novo Nordisk GLP-1 injections would be forced to slash prices." At present, the weekly subcutaneous injection of semaglutide product ozempic is priced at $770, while the daily subcutaneous injection of the old GLP-1 drug Victoza (lilalutide) is priced at $920 To avoid cannibalizing the company's other products of the same type, Novo Nordisk executives have previously hinted at "a preference for pricing similar to GLP-1 injections." Although the price may have caused some dissatisfaction in the market, Jefferies analysts pointed out that the price has exceeded the consistent feedback of investors who expected the company's GLP-1 injection to reduce its price However, the key data of rybelsus listing will be the discounted price provided by Novo Nordisk, which will not be disclosed to the public So far, Novo Nordisk has said it has received positive feedback from the payer on the clinical profile of rybelsus and its own cost-benefit research In view of Novo Nordisk's hope to position rybelsus as early as possible in the treatment mode of type 2 diabetes with metformin treatment failure, the company may offer a greater discount to payers than ozempic in rybelsus As the world's first oral GLP-1 antidiabetic drug, rybelsus has a very good business prospect in the industry Evaluatepharma forecasts that rybelsu's global sales are expected to reach $3.325 billion in 2024 In addition to pricing, another determinant of rybelsu's sales prospects is whether its product information can be successfully labeled as reducing cardiovascular (CV) risk Currently, rybelsus and ozempic's application for CV risk reduction in adult patients with type 2 diabetes is under review by the U.S FDA, and the review results are expected to be obtained in January 2020 The application is based on the results of two CV prognostic studies These studies were conducted in adults with type 2 diabetes who were at high risk for CV events and assessed the impact of semaglutide or placebo addition to standard care on CV event risk According to the data of pioneer 6 study, the risk of major adverse cardiovascular events (MACE) was reduced by 21% by oral semaglutide compared with placebo, reaching the main end point of non inferiority effect, but there was no statistical significance However, compared with placebo, oral semaglutide significantly reduced the risk of cardiovascular death by 51%, all-cause mortality by 49%, non fatal myocardial infarction and non fatal stroke Data from the sustain 6 study showed that ozempic significantly reduced the risk of major adverse mace composite endpoints by 26% compared to placebo when combined with standard care In the above two studies, pionner 6 showed non inferiority rather than superiority, while sustain 6 did not include superiority analysis Therefore, it is not clear whether rybelsus and ozempic can ensure cardiovascular labeling early next year Novo Nordisk may need to wait for data from a larger cvot study, such as the rybelsus study of 9600 patients, launched earlier this year The study will not be completed until 2024, but the mid-term analysis may provide an opportunity to win earlier Regarding the study, Novo Nordisk said that "patient recruitment is progressing smoothly" at present Launching a soul study before the FDA's cardiovascular labeling review decision appears to be a costly but potentially necessary insurance strategy According to the R & D cost model of evaluatepharma vision, it is estimated that soul research will cost about 300 million US dollars Reference sources: 1 Pricing questions remain as novo gets the nod for Oracle SEMA 2 Novo prices or rybelsus on par with injectable rivals, ending discount feeds