This article is reproduced from the U.S. Chinese Medicine Source
[News event]: Today, Merck and Pfizer announced that they will double the number of people in the safety trial of the SGLT inhibitor Ertugliflozin to be upgraded to a efficacy trial. This trial will not only study whether Ertugliflozin can safely lower blood sugar, but also the ability to detect cardiovascular benefits. Today the two giants also announced the hypoglycemic effect of Ertugliflozin. High-dose Ertugliflozin alone can reduce HbA1c by 1.16%, and the combination with Merck’s DPP4 inhibitor Januvia can reduce HbA1c by 1.5%. Ertugliflozin is expected to apply for listing this year.
[Drug Source Analysis]: Diabetes is one of the chronic diseases that affect the most people in the world, and the market is now as high as 70 billion U.S. dollars. The most serious side effect is cardiovascular disease, among which 60% of diabetic patients die of cardiovascular disease. Since the Avandia incident, the FDA has required all hypoglycemic drugs to be shown to be safe for hypoglycemic. Last year, Eli Lilly and BI's SGLT inhibitor Jardiance unexpectedly showed that it can not only lower blood sugar safely, but also reduce heart failure events. Because the effect of heart failure takes effect rapidly and may be through a non-hyperglycemic mechanism, Eli Lilly is preparing to start a heart failure clinical trial of Jardiance this year, which may threaten the reincarnation of Novartis's antihypertensive drug Entresto. Another type of hypoglycemic drug GLP-1 agonist has recently shown benefits from cardiovascular events. Novo Nordisk’s LEADER trial results will be announced tomorrow.
The benefits of reducing blood sugar for type 1 diabetes are indisputable. Insulin turns a terminal illness of a child into a chronic disease, which is one of the most successful discoveries in modern medicine. However, type 2 diabetes is usually not related to insulin secretion, but insulin resistance due to many reasons. In the past, hypoglycemic drugs rarely showed microcirculation and macrocirculation benefits except for lowering blood sugar. Therefore, doctors and patients all regard safe hypoglycemia as the primary curative effect. But now diabetes treatment is also paying more and more attention to benefits other than hypoglycemic, especially two types of drugs have shown cardiovascular benefits, including SGLT inhibitors. As the fourth SGLT inhibitor on the market, Ertugliflozin will be severely restricted if it can only safely lower blood sugar. Merck’s current number one product, Januvia, has no evidence of cardiovascular benefits. Although the patent has not yet expired, sales have begun to decline.
Contrary to the sudden increase in Ertugliflozin investment, Merck just stopped the development of the long-acting DPP4 inhibitor Omarigliptin last month, although this product has already undergone 7,000 clinical trials. Both of these adjustments are correct responses to changes in the current pharmaceutical consumption environment. Even for the long-term use of antidiabetic drugs for chronic diseases, ease of use and efficacy ratio are already secondary factors. This adjustment of development strategy involves the direction of investment of hundreds of millions of dollars and requires rich experience in decision-making. This is why Pfizer has discovered Ertugliflozin on its own, but it has to cooperate with Merck to develop it. Merck has accumulated a lot of experience in the development of diabetes drugs due to Januvia. Of course, the strong combination with Januvia is also an important factor.
There are many differences in the development of drugs for the treatment of diabetes and tumors. Tumor drugs focus on extending lifespan as their core efficacy, and tumor shrinkage is only used as auxiliary evidence, and until recently, safe hypoglycemia was the only expectation of doctors. US$100,000 a year for oncology drugs is common, but diabetes drugs are used for a long time and involve a huge number of people, so the price is an important factor. Safe and cheap metformin is the absolute first-line drug in the western market. Oncology drugs can be marketed in clinical trials with one or two hundred people, and Ertugliflozin plans to enroll 12,600 patients in nine large-scale clinical trials. Both have their pros and cons, and free competition will determine the final balance.
