Mercedon 15-price pneumonia vaccine and Bayerfinerenone were granted priority review by the FDA

On January 12, Mercedon announced that the FDA had accepted priority review of the company's biopharmaceus 15 pneumococcal binding vaccine V114 for the prevention of invasive pneumococcal disease in adults 18 years of age and older.
the FDA has set the Prescription Drug User Costs Act (PDUFA) or target action date as July 18, 2021.
, the European Medicines Agency (EMA) is also reviewing applications for licenses for adult V114 vaccines.
Mershaton noted that the BLA and priority review designations were supported by a number of Phase 2 and Phase 3 clinical studies on V114 in adult populations, including healthy adults and those at increased risk, including adults with chronic diseases, adults living with HIV and older persons 65 years and older.
BLA's other studies support the potential application of V114 in a variety of real-world clinical settings, including co-dosing with the four-price influenza vaccine, as well as as sequential dosing with the 23-price pneumococcal polysaccharide vaccine Pneumovax 23, and have demonstrated the equivalent performance of successive batches of V114.
Pneumovax 23 is an active immunization vaccine for the prevention of 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F) contained in the vaccine pneumococcal disease caused by pneumococcal diseases caused by pneumococcal diseases caused by 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F, which is approved for use in populations aged ≥2 and 50 years or older, with an increased risk of pneumococcal disease.
and V114 consist of 15 serotypes of pneumococcal polysaccharides, which bind to CRM197 vector proteins, including 22F and 33F serotypes, which are commonly associated with invasive pneumococcal diseases in older adults worldwide and are not included in the pneumococcal binding vaccine currently available for adult use.
is also developing V114 for child prevention.
same day, Bayer, another pharmaceutical giant, announced that the FDA had accepted a new drug application (NDA) for its experimental drug Finerenone for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) and granted priority review.
FDA will take approval action within six months of the NDA's acceptance, and the PDUFA date for the Yommersadon vaccine V114 is expected to be similar.
bayer, NDA and priority reviews are based on Phase 3 clinical trial FIDELIO-DKD data.
the study included 5,734 CKD combined T2D patients in more than 1,000 centres in 48 countries worldwide, with an average age of 138 mmHg, an average baseline systolic blood pressure of 138mmHg, an average diabetes range of nearly 17 years, an average baseline HbA 1c of 7.7 per cent, about 63 per cent of whites, 25 per cent of Asians and less than 5 per cent of blacks.
of follow-up was 2.6 years.
major compound endpoints of the study included renal failure, kidney death, and a decrease in the rate of renal cyspheric filtration (eGFR) from the baseline.
3.4 percent lower risk of kidney adverse outcomes and 18 percent lower relative risk in patients in the Finerenone group.
secondary compound endpoints include the first cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure.
of cardiovascular adverse outcomes decreased by 2.4% and the relative risk by 14% in patients in the Finerenone group.
of the leading causes of kidney and cardiovascular damage is the inflammatory and fibrosis process caused by overactivation of the salt corticosteroids.
Finerenone (BAY 94-8862) is a potential "first-in-class", a research, nonsteroidal, selective salt corticosteroid-like antagonist (MRA) that has been shown to reduce many of the harmful effects of overactivation of salt corticosteroids (MR).
including fidelio-DKD, the drug's Phase 3 trial of CKD and T2D randomly selected 13,000 patients with different disease severity, involving patients with early kidney damage and advanced kidney disease.
this is by far the largest Phase III clinical trial project for CKD and T2D, including two studies that assessed the effects of fentanyl and placebo on kidney and cardiovascular outcomes, respectively.
source: 1.U.S. FDA grants Review to New Drug Application for finerenone to treat patients with chronic kidney disease and type 2 diabetes 2.U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck's Investigational 15-valent Pneumococcal Conjugate Vaccine, For Adults 18 Years and Age Disease Outcomes in Type 2 Diabetes