Pazopanib HCL intermediates manufacturer
Boehringer Ingelheim Lilly announced that it had formally submitted to the China Drug Administration (nmpa) on October 29, 2020 the registration application of empagliflozin, the sglt-2 inhibitor of the Diabetes Federation, for the treatment of adult patients with heart failure with or without diabetes and reduced ejection fraction.
This is the second indication of engliegin's application in China. It is worth mentioning that the application for registration has been submitted simultaneously with the United States and the European Union, only six days later than that in the United States. Previously, engleglin has been approved in China for the treatment of type 2 diabetes mellitus. In combination with diet control and exercise, it can improve blood glucose control in patients with type 2 diabetes by monotherapy, combined with metformin or combined with metformin and sulfonylureas. The global sales of this product will be about US $3.4 billion in 2019.
The application for registration of engliptin for the treatment of adult patients with heart failure with reduced ejection fraction is mainly based on the expert reduced study in the expert heart failure study. The expert reduced study reached a pre-set primary endpoint. The results of the clinical trial were published in the New England Journal of medicine in 2020.
About Emperor heart failure study:
Two phase III, randomized, double-blind trials were conducted in adult patients with chronic heart failure (both with and without diabetes mellitus) with preserved and reduced ejection fraction (EF) to study the efficacy and safety of once daily engliglin compared with placebo on the basis of standard treatment Security;
Emperor reduced study: To evaluate the safety and efficacy of engliptin in patients with chronic heart failure (hfref) with reduced ejection fraction. The study was a randomized, placebo-controlled trial to study the safety and efficacy of engliptin in 3730 patients with hfref, regardless of diabetes mellitus. The primary end point was the length of time to first conviction of cardiovascular death or hospitalization for heart failure (HHF).
Emperor preserved study: To evaluate the safety and efficacy of engliptin in patients with chronic heart failure (HFPEF) with preserved ejection fraction. The primary end point was the length of time to first conviction of cardiovascular death or hospitalization for heart failure (HHF).
