First, oral somaglutide tablets pricing:
Recently, the price of Novo Nordisk oral sumaglutide tablets, (7mg, 14mg) specifications are 26 US dollars / day, 772 US dollars / 30 tablets, about 5500 yuan / month. It is valuable, but it is close to the price of somaglutide for injection. It is expected to launch a sales in the fourth quarter.
Oral semaglutide (project code: NN9924) is an oral preparation containing SNAC tablets. SNAC is an excipient that promotes absorption and is made of (8-(2-hydroxybenzamide) sodium octanoate). Eligen® technology is based on a variety of macromolecule delivery technologies that use Eligen® technology licensed from Emisphere Technologies, Inc.
Previously, Professor Jin Tuo from Shanghai Jiaotong University issued a paper discussing the view that this oral approval was only a starting point and still has great challenges. Specific click: Professor Jin Tuo talks about hot spots: oral somaglutide.
Second, in March 2019, Novo Nordisk submitted a number of oral somaglutide market application (NDA) to the US FDA.
(1) Item 1 NDA, applied for oral semaglutide for the treatment of adult patients with type 2 diabetes.
Based on the expanded PIONEER clinical data, including 10 clinical studies, a total of 9543 patients with type 2 diabetes were enrolled. A control trial with sitagliptin (Mermazone's DPP-4 inhibitor), nglipepsin (SGLT-2 inhibitor), liraglutide, and placebo was developed. The results showed that patients treated with oral semaglutide (7 mg and 14 mg) had a greater reduction in blood glucose levels. Oral semaglutide reduced mean body weight more significantly than most control drugs. (This study was published in the JAMA magazine)
(2) For the NDA, Novo Nordisk re-invested and used a Priority review voucher (PRV) to speed up the NDA review, shortening the standard duration from 10 months to 6 months. . In September 2019, oral somaglutide was approved by the FDA. The product name is Rybelsus®, once a day (7mg/14mg size) for glycemic control in patients with type 2 diabetes.
(3) One of the randomized, double-blind, double-simulated, parallel-group 3a trials of semaglutide and sitagliptin was administered once daily. From February 2016 to March 2018, a total of 78 weeks of clinical research was conducted in 206 regions in 14 countries. A total of 1864 patients with type 2 diabetes who were treated with metformin ± sulfonylureas to control hypoglycemia were enrolled from 2,463 patients and randomized.
Patients were randomized to oral semaglutide 3 mg (n = 466), oral semaglutide 7 mg (n = 466), oral semaglutide 14 mg (n = 465), and sitagliptin 100 mg (n = 467). The initial dose of oral semaglutide was 3 mg/d, up every 4 weeks, first to 7 mg/d, then to 14 mg/d until a randomized dose was reached.
The primary endpoint of the study was: changes in glycated hemoglobin (HbA1c) from baseline to week 26; secondary endpoints: changes in body weight from baseline to week 26.
Of the 1864 patients randomized (mean age 58 years, mean baseline HbA1c 8.3%, mean body mass index 32.5, 879 women), 1758 (94.3%) completed the trial and 298 discontinued treatment. HbA1c was significantly lower in the 7 mg group and the 14 mg group than in the sitagliptin group (differences were -0.3% [95% CI, -0.4% to -0.1%] and -0.5% [95% CI, -0.6%~- 0.4%], P <0.001); body weight also decreased significantly from baseline to week 26 (differences -1.6 kg [95% CI, -2.0 to -1.1 kg] and -2.5 kg [95% CI, -3.0) ~-2.0 kg], P <0.001). The two endpoints of the somaglutide 14 mg group were more markedly reduced at week 78 compared with sitagliptin.
Third, At the end of June 2019, Novo Nordisk's efficacy and safety comparison between oral semaglutide and sitagliptin in patients with type 2 diabetes treated with metformin (NN9924-4309) The third phase of clinical practice is approved by the genetics office. (Peking University People's Hospital). The clinical data of oral semaglutide is excellent, and the clinical trial in China is expected to end soon.
