A Bayer drug for the treatment of renal dysfunction in patients with type 2 diabetes is now on the market FDA approved, To provide the pharmaceutical giant with a product that can compete with existing therapies sold by AstraZeneca and Johnson & Johnson.
People with type 2 diabetes are at a high risk of kidney problems, including chronic kidney disease-damage to organs that prevent them from filtering blood properly. Ineffective filtration can cause a series of other complications, which may lead to kidney failure.
The US Food and Drug Administration approved Bayer’s drug Finerenone on Friday to reduce the risk of decreased renal function, kidney failure or cardiovascular problems in adults with chronic kidney disease and type 2 diabetes. Bayer will sell this once-a-day tablet under the name “Kerendia”.
The scar tissue and inflammatory features of chronic kidney disease are thought to be related to the excessive activation of mineralocorticoid receptors. Bayer’s Kerendia aims to block this receptor. The drug is the first drug approved to treat chronic kidney disease in this way. This is a different approach from AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana, which belong to a class of type 2 diabetes drugs called SGLT2 inhibitors. Invokana’s label includes reducing the risk of end-stage renal disease. According to Johnson & Johnson’s annual report, the drug generated $795 million in revenue in 2020. Farxiga has global sales of 1.9 billion US dollars in 2020, Add chronic kidney disease To its label in April.
The FDA’s approval of Bayer’s drugs is based on the results of a double-blind, placebo-controlled Phase 3 study that enrolled 5,674 adults with chronic kidney disease and type 2 diabetes. The patients were randomly assigned to receive Bayer drug or placebo, and the median follow-up time was 2.6 years.
The goal of the study is to evaluate patients based on combined endpoints, including a decline in renal function of at least 40%, progression to renal failure, or death due to kidney problems. The study showed that patients taking Kerendia had a significantly reduced risk of these problems, with 504 of the 2,833 patients in the test drug group having at least one of these events, and 600 of the 2,841 patients receiving a placebo.
The patients in the study were also evaluated for cardiovascular death, non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure. Based on these secondary cardiovascular goals, the incidence of Bayer drugs was also significantly reduced compared with the placebo group.The complete research result is Publish In the New England Journal of Medicine at the end of last year.
The side effects reported in the trial included high blood potassium levels, low blood pressure, and low sodium levels. The Kerendia label warns patients not to take this drug with other CYP3A4 inhibitor drugs. Blocking CYP3A4 (an enzyme found in the liver and intestines) can cause the effects of Kerendia to be amplified to potentially dangerous levels. Patients are also warned not to consume grapefruit or grapefruit juice, which are also CYP3A4 inhibitors.
Bayer expects Kerendia is available In the United States at the end of this month. The company also submitted the drug for regulatory review in Europe.
Photo by Bayer
