Kerendia Receives FDA Approval for Slowing chronic kidney disease in Type 2 Diabetes

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Author:华讯知识产权
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Time of issue:2021-07-15 11:00
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(Summary description)Kerendia Receives FDA Approval for Slowing chronic kidney disease in Type 2 Diabetes This month FDA announced that they have approved Kerendia (finerenone) tablets for the treatment of patients with chronic kidney disease associated with type 2 diabetes. Kerendia is indicated to delay chronic kidney disease progression. It is able to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adult diabetic patients. Now the drug has also been submitted for marketing authorization in China, European Union and other countries. There are 422 million people with diabetes, and there are up to 40% of all patients with type 2 diabetes develop chronic kidney disease. Diabetes is one of the most common causes of chronic kidney disease and kidney failure. Chronic kidney disease is the gradual loss of kidney function over a period of months to years. It occurs when the kidneys are damaged and cannot filter blood normally, and sometimes can progress to kidney failure. The patients are also at high risk of heart disease because of defective filtering. Kerendia is the first and only nonsteroidal mineralocorticoid receptor antagonist (MRA) for Type 2 diabetic patients with chronic kidney disease, compared to SGLT2 inhibitors, Farxiga (dapagliflozin) and Invokana (canagliflozin). It blocks overactivation of the mineralocorticoid receptor (MR) which contributes to fibrosis and inflammation. The drug is able to target fibrosis and inflammation to slow kidney disease progression. The efficacy of Kerendia was evaluated in a randomized, multicenter, double-blind, placebo-controlled in the phase III trial. There were 5,674 patients in the study. The study found that Kerendia beat placebo when it came to kidney function. That included fending off or slowing progression to kidney failure and kidney death. Furthermore, the study also found that Kerendia reduced the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure. Kerendia received priority review and fast track designations for their application, and it will be commercially available in the U.S. by the end of July. 資料來源： https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease https://www.pharmalive.com/bayers-kerendia-receives-u-s-fda-approval/ https://finance.yahoo.com/news/bayers-kerendia-scores-long-awaited-111105329.html https://www.businesswire.com/news/home/20210709005441/en/Bayer%E2%80%99s-KERENDIA%C2%AE-finerenone-Receives-U.S.-FDA-Approval-for-Treatment-of-Patients-with-Chronic-Kidney-Disease-Associated-with-Type-2-Diabetes https://www.healio.com/news/endocrinology/20200710/finerenone-delays-diabetic-kidney-disease-progression-fideliodkd

Kerendia Receives FDA Approval for Slowing chronic kidney disease in Type 2 Diabetes

(Summary description)Kerendia Receives FDA Approval for Slowing chronic kidney disease in Type 2 Diabetes

This month FDA announced that they have approved Kerendia (finerenone) tablets for the treatment of patients with chronic kidney disease associated with type 2 diabetes. Kerendia is indicated to delay chronic kidney disease progression. It is able to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adult diabetic patients. Now the drug has also been submitted for marketing authorization in China, European Union and other countries.

There are 422 million people with diabetes, and there are up to 40% of all patients with type 2 diabetes develop chronic kidney disease. Diabetes is one of the most common causes of chronic kidney disease and kidney failure. Chronic kidney disease is the gradual loss of kidney function over a period of months to years. It occurs when the kidneys are damaged and cannot filter blood normally, and sometimes can progress to kidney failure. The patients are also at high risk of heart disease because of defective filtering.

Kerendia is the first and only nonsteroidal mineralocorticoid receptor antagonist (MRA) for Type 2 diabetic patients with chronic kidney disease, compared to SGLT2 inhibitors, Farxiga (dapagliflozin) and Invokana (canagliflozin). It blocks overactivation of the mineralocorticoid receptor (MR) which contributes to fibrosis and inflammation. The drug is able to target fibrosis and inflammation to slow kidney disease progression.

The efficacy of Kerendia was evaluated in a randomized, multicenter, double-blind, placebo-controlled in the phase III trial. There were 5,674 patients in the study. The study found that Kerendia beat placebo when it came to kidney function. That included fending off or slowing progression to kidney failure and kidney death. Furthermore, the study also found that Kerendia reduced the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure.

Kerendia received priority review and fast track designations for their application, and it will be commercially available in the U.S. by the end of July.

資料來源：

https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease
https://www.pharmalive.com/bayers-kerendia-receives-u-s-fda-approval/
https://finance.yahoo.com/news/bayers-kerendia-scores-long-awaited-111105329.html
https://www.businesswire.com/news/home/20210709005441/en/Bayer%E2%80%99s-KERENDIA%C2%AE-finerenone-Receives-U.S.-FDA-Approval-for-Treatment-of-Patients-with-Chronic-Kidney-Disease-Associated-with-Type-2-Diabetes
https://www.healio.com/news/endocrinology/20200710/finerenone-delays-diabetic-kidney-disease-progression-fideliodkd

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2021-07-15 11:00
Views:

Information

Kerendia Receives FDA Approval for Slowing chronic kidney disease in Type 2 Diabetes

This month FDA announced that they have approved Kerendia (finerenone) tablets for the treatment of patients with chronic kidney disease associated with type 2 diabetes. Kerendia is indicated to delay chronic kidney disease progression. It is able to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adult diabetic patients. Now the drug has also been submitted for marketing authorization in China, European Union and other countries.

There are 422 million people with diabetes, and there are up to 40% of all patients with type 2 diabetes develop chronic kidney disease. Diabetes is one of the most common causes of chronic kidney disease and kidney failure. Chronic kidney disease is the gradual loss of kidney function over a period of months to years. It occurs when the kidneys are damaged and cannot filter blood normally, and sometimes can progress to kidney failure. The patients are also at high risk of heart disease because of defective filtering.

Kerendia is the first and only nonsteroidal mineralocorticoid receptor antagonist (MRA) for Type 2 diabetic patients with chronic kidney disease, compared to SGLT2 inhibitors, Farxiga (dapagliflozin) and Invokana (canagliflozin). It blocks overactivation of the mineralocorticoid receptor (MR) which contributes to fibrosis and inflammation. The drug is able to target fibrosis and inflammation to slow kidney disease progression.

The efficacy of Kerendia was evaluated in a randomized, multicenter, double-blind, placebo-controlled in the phase III trial. There were 5,674 patients in the study. The study found that Kerendia beat placebo when it came to kidney function. That included fending off or slowing progression to kidney failure and kidney death. Furthermore, the study also found that Kerendia reduced the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure.

Kerendia received priority review and fast track designations for their application, and it will be commercially available in the U.S. by the end of July.

資料來源：

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Electronic Arts pledges free use for five accessibility patents

Electronic Arts pledges free use for five accessibility patents Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The code of the mentioned technology is published on EA’s GitHub, and it is open to all developers. Thus, the developers can use it or adapt it for their games without spending the costs to research. It is good that EA shares the patents for free use and aims to create an accessibility-increased gaming environment for players. However, it is not “unconditional” to use the listed patents. In the pledge, EA mentioned that it may terminate the promise for a specific party which files a patent infringement lawsuit or other patent proceedings against EA. We can see parts of EV’s ambition behind the announcement—to build a large game developer league and a community of shared interests. Reference: https://www.ea.com/commitments/positive-play/accessibility-patent-pledge https://iknow.stpi.narl.org.tw/Post/Read.aspx?PostID=14562 https://www.polygon.com/22639469/apex-legends-electronic-arts-patent-pledge-accessibility-developers https://www.theverge.com/2021/8/24/22638535/ea-accessibility-patent-pledge-apex-legends-ping-system https://www.gamesradar.com/ea-secures-a-patent-for-the-apex-legends-ping-system-and-its-giving-it-away-for-free/ https://dotesports.com/apex-legends/news/apex-legends-ping-system-is-now-patent-free-for-accessibility https://www.nintendolife.com/news/2021/08/apex_legends_ping_system_now_patent-free_as_ea_announces_accessibility_pledge Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The

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