Istradefylline

Biotech Sector Working Fast to Combat Alzheimer's Disease Cases That are Set to Explode

Retrieved on: 
Wednesday, March 15, 2023

VANCOUVER, B.C., March 15, 2023 /PRNewswire/ -- March 15, 2023 - USA News Group - According to a 2022 study of more than 6 million patients 65 and older, the risk factor for developing Alzheimer's disease increases by 50-80% in older adults who caught COVID-19. With Statista stating nearly 11.5 million COVID-19 cases of people over 65 years old as of November 23, 2022, and the Alzheimer's Association forecasting global dementia cases to triple by 2050, society is about to get hit with a tsunami of this devastating disease. Thankfully the biotech sector is working diligently to try and combat this coming onslaught of Alzheimer's and dementia, through new diagnostic methods and treatments, including work from companies such as Marvel Biosciences Corp. (TSXV:MRVL), Biogen Inc. (NASDAQ:BIIB), Prothena Corporation plc (NASDAQ:PRTA), Intra-Cellular Therapies (NASDAQ:ITCI), and Roche Holding AG (OTC:RHHBY).

Key Points: 
  • In the case of Marvel Biosciences Corp. (TSXV:MRVL), the biotech company is moving forward with its lead asset MB-204 in targeting Alzheimer's and depression .
  • MB-204 is a novel fluorinated derivative of Istradefylline, the only clinically approved adenosine A2a receptor antagonist used for the treatment of Parkinson's disease.
  • Caffeine consumption has been associated with a reduced risk for developing Parkinson's disease, Alzheimer's disease and improving mood and concentration.
  • MB-204 will be highly disruptive to the existing market and, we believe, will be a welcomed therapy for patients who suffer from Alzheimer's Disease and Depression.

Biotech Sector Working Fast to Combat Alzheimer's Disease Cases That are Set to Explode

Retrieved on: 
Wednesday, March 15, 2023

VANCOUVER, B.C., March 15, 2023 /PRNewswire/ -- March 15, 2023 - USA News Group - According to a 2022 study of more than 6 million patients 65 and older, the risk factor for developing Alzheimer's disease increases by 50-80% in older adults who caught COVID-19. With Statista stating nearly 11.5 million COVID-19 cases of people over 65 years old as of November 23, 2022, and the Alzheimer's Association forecasting global dementia cases to triple by 2050, society is about to get hit with a tsunami of this devastating disease. Thankfully the biotech sector is working diligently to try and combat this coming onslaught of Alzheimer's and dementia, through new diagnostic methods and treatments, including work from companies such as Marvel Biosciences Corp. (TSXV:MRVL), Biogen Inc. (NASDAQ:BIIB), Prothena Corporation plc (NASDAQ:PRTA), Intra-Cellular Therapies (NASDAQ:ITCI), and Roche Holding AG (OTC:RHHBY).

Key Points: 
  • In the case of Marvel Biosciences Corp. (TSXV:MRVL), the biotech company is moving forward with its lead asset MB-204 in targeting Alzheimer's and depression .
  • MB-204 is a novel fluorinated derivative of Istradefylline, the only clinically approved adenosine A2a receptor antagonist used for the treatment of Parkinson's disease.
  • Caffeine consumption has been associated with a reduced risk for developing Parkinson's disease, Alzheimer's disease and improving mood and concentration.
  • MB-204 will be highly disruptive to the existing market and, we believe, will be a welcomed therapy for patients who suffer from Alzheimer's Disease and Depression.

Kyowa Kirin Provides Update on Application for Marketing Authorisation of Istradefylline in Europe for the Treatment of ‘OFF’ Episodes in People Living with Parkinson’s

Retrieved on: 
Friday, July 23, 2021

Kyowa Kirin International remain committed to istradefylline and people living with Parkinsons and are currently reviewing the options available, which may include re-examination.

Key Points: 
  • Kyowa Kirin International remain committed to istradefylline and people living with Parkinsons and are currently reviewing the options available, which may include re-examination.
  • First of all, I would like to appreciate those who have contributed to the development of istradefylline.
  • You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/ .
  • Kyowa Kirin International is a subsidiary of Kyowa Kirin Co., Ltd.

Impact of Baseline Dyskinesia on Safety and Efficacy of NOURIANZ® (istradefylline) in Patients with Parkinson's Disease Presented During "Virtual" European Academy of Neurology Meeting

Retrieved on: 
Tuesday, May 26, 2020

These findings were presented during the 6th Congress of the European Academy of Neurology (EAN).

Key Points: 
  • These findings were presented during the 6th Congress of the European Academy of Neurology (EAN).
  • "The results being presented at EAN suggest that dyskinesia is observed more often in patients with baseline dyskinesia before istradefylline was added to the treatment regimen and that the overall efficacy of istradefylline was not affected by patients' baseline status.
  • While these data provide further information, physicians should continue to monitor patients for dyskinesia or exacerbation of existing dyskinesia during NOURIANZ treatment.
  • Impact of Baseline Dyskinesia on the Safety and Efficacy of Istradefylline, an Adenosine A2A Receptor Antagonist, in Patients with Parkinson's Disease: a Pooled Analysis of 8 Clinical Studies.

Kyowa Kirin Announces Marketing Authorisation Application for Istradefylline Validated by European Medicines Agency

Retrieved on: 
Monday, January 6, 2020

TOKYO, Jan. 6, 2020 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) President and CEO: Masashi Miyamoto, "Kyowa Kirin") today announces that its marketing authorisation application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson's disease (PD) experiencing "OFF" time, has been validated by the European Medicines Agency (EMA) and is now under review.

Key Points: 
  • TOKYO, Jan. 6, 2020 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) President and CEO: Masashi Miyamoto, "Kyowa Kirin") today announces that its marketing authorisation application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson's disease (PD) experiencing "OFF" time, has been validated by the European Medicines Agency (EMA) and is now under review.
  • "Parkinson's disease is the fastest growing neurological disorder in the world in terms of prevalence, disability and deaths1," said Abdul Mullick, President, Kyowa Kirin International (Europe, Middle East and Africa (EMEA)).
  • Kyowa Kirin focuses on creating new values in the four therapeutic areas: nephrology, oncology, immunology/allergy and neurology.
  • Istradefylline was approved in Japan (product name: NOURIAST) in March 2013 for improving the "wearing-off" phenomenon in patients with Parkinson's disease on levodopa-containing preparations.

Kyowa Kirin Announces Marketing Authorisation Application for Istradefylline Validated by European Medicines Agency

Retrieved on: 
Monday, January 6, 2020

TOKYO, Jan. 6, 2020 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) President and CEO: Masashi Miyamoto, "Kyowa Kirin") today announces that its marketing authorisation application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson's disease (PD) experiencing "OFF" time, has been validated by the European Medicines Agency (EMA) and is now under review.

Key Points: 
  • TOKYO, Jan. 6, 2020 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) President and CEO: Masashi Miyamoto, "Kyowa Kirin") today announces that its marketing authorisation application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson's disease (PD) experiencing "OFF" time, has been validated by the European Medicines Agency (EMA) and is now under review.
  • "Parkinson's disease is the fastest growing neurological disorder in the world in terms of prevalence, disability and deaths1," said Abdul Mullick, President, Kyowa Kirin International (Europe, Middle East and Africa (EMEA)).
  • Kyowa Kirin focuses on creating new values in the four therapeutic areas: nephrology, oncology, immunology/allergy and neurology.
  • Istradefylline was approved in Japan (product name: NOURIAST) in March 2013 for improving the "wearing-off" phenomenon in patients with Parkinson's disease on levodopa-containing preparations.

Kyowa Kirin Announces NOURIANZ™ (Istradefylline) Now Available in the U.S. for Treatment of Parkinson’s Disease “Off” Episodes

Retrieved on: 
Monday, October 14, 2019

Kyowa Kirin, Inc. (Kyowa Kirin), an affiliate of Kyowa Kirin Co., Ltd. (TSE: 4151), announced today that NOURIANZ (istradefylline) is now available in the U.S. as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinsons disease (PD) experiencing off episodes.

Key Points: 
  • Kyowa Kirin, Inc. (Kyowa Kirin), an affiliate of Kyowa Kirin Co., Ltd. (TSE: 4151), announced today that NOURIANZ (istradefylline) is now available in the U.S. as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinsons disease (PD) experiencing off episodes.
  • To help patients with questions about access to NOURIANZ, Kyowa Kirin offers the Kyowa Kirin Cares program.
  • NOURIANZ (istradefylline) is an adenosine receptor antagonist indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinsons disease (PD) experiencing off episodes.
  • Parkinsons disease is a progressive, neurodegenerative disease characterized by motor symptoms such as tremors, rigidity, slow movement and postural instability.

Kyowa Kirin Announces FDA Approval of NOURIANZ™ (istradefylline) for Use in Parkinson’s Disease

Retrieved on: 
Wednesday, August 28, 2019

Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for NOURIANZ (istradefylline) for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinsons disease (PD) experiencing OFF episodes.

Key Points: 
  • Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for NOURIANZ (istradefylline) for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinsons disease (PD) experiencing OFF episodes.
  • We are proud that NOURIANZ is now ready to help adult patients with Parkinsons disease in the US, said Tomohiro Sudo, Head of Global Product Management Office of Kyowa Kirin.
  • We are grateful for the FDA approval and for the many dedicated scientists and patients whose participation in our research programs has resulted in a new treatment option for Parkinson's disease.
  • Parkinsons disease is a progressive, neurodegenerative disease characterized by motor symptoms such as tremors, rigidity, slow movement and postural instability.

Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US

Retrieved on: 
Thursday, April 4, 2019

The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in August 27, 2019.

Key Points: 
  • The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in August 27, 2019.
  • "We are excited by the possibility of bringing a new medicine to people living with Parkinson's Disease and look forward to working closely with FDA during the review process."
  • Istradefylline, is an A2A receptor antagonist, and if approved by FDA, may provide a novel non-dopaminergic pharmacologic approach to treating OFF episodes for people living with PD.
  • Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies.