① Pharmaceutical manufacturer Novo Nordisk is doing its best to push for approval of the pill version of simeglutide. It is reported that the drug will be marketed as soon as next year;
② At the same time, competitors such as Eli Lilly, Pfizer, and AstraZeneca are also competing in the field of oral films.
Since this year, the attention of simeglutide, which has been dubbed the “magic medicine for weight loss,” has remained “high fever”. Pharmaceutical manufacturers$Novo-Nordisk A/S(NVO.US)$They are not slacking off at all, and are doing their best to push for approval of the pill version of simeglutide. It is reported that the drug will be marketed as soon as next year.
According to information, the oral version of simetaglutide passed approval by the US Food and Drug Administration (FDA) as early as 2019, but it is only used to treat type 2 diabetes. The trade name is “Rybelsus,” which is the first approved oral GLP-1 drug in the world.
It has the same active ingredient in the drug as the popular diet pill “Wekovy” in Europe and the US. However, compared with weight loss needles, oral tablets have huge advantages. They have excellent convenience, better storage and transportation, stable curative effects, fewer contraindications, and are more conducive to large-scale production to reduce costs, and are bound to become an important flashpoint.
At the same time,$Eli Lilly and Co(LLY.US)$,$Pfizer(PFE.US)$,$AstraZeneca(AZN.US)$Other competitors are also scrambling to compete in the field of oral films. Two months ago, Pfizer CEO Albert Bourla (Albert Bourla) said that oral tablets will play a very important role because not everyone can receive injectable treatment.
AstraZeneca CEO Pascal Soriot (Pascal Soriot) pointed out that oral medications can allow more people from low-income countries to use them. However, Rybelsus has yet to achieve this; the drug has the same list price as the diabetes injection “Ozempic” (Ozempic), which costs $936 a month.
A month ago, Novo Nordisk registered a phase III study on the ClinicalTrials.gov website to evaluate the efficacy and safety of simetaglutide tablets versus englyprizine or metformin tablets in the treatment of newly diagnosed patients with type 2 diabetes. If positive results are achieved, Rybelsus is expected to seize further market share.
But the pill still has limitations: patients need to take it every day on an empty stomach, then wait another half an hour before eating, and the highest-dose version reports significantly more gastrointestinal side effects. In response, Eli Lilly executives stated that their drug Orforglipron did not have these restrictions.
Joon Lee, a senior biotech analyst at Truist Securities, told the media that Lilly's drug “looks the best,” and although it may still be some time before commercialization, it has given Lilly the potential to compete with Novo Nordisk in this field.
Pfizer, on the other hand, is clearly far behind. The company announced in June that it has decided to abandon the second-generation Lotiglipron and make every effort to promote the first-generation Danuglipron. The explanation given by Pfizer is that the second-generation Lotiglipron was a safety sign of elevated aminotransferase in early clinical trials, while this problem was not detected in the first-generation Danuglipron.
Other than that,$Viking Therapeutics(VKTX.US)$with$Structure Therapeutics(GPCR.US)$... and other biotech companies are also testing diet pills. BMO capital markets analyst Evan David Seigerman wrote in a report that Structure is in the mid-term human trials stage, and its encouraging results are “definitely ahead” of Pfizer.