Accelerated approval

Biogen and Eisai Announce ADUHELMTM (aducanumab-avwa) Data Presentations at Alzheimer's Association International Conference 2021

Retrieved on: 
Tuesday, July 27, 2021
Branches of biology, Alzheimer's disease, Amyloidosis, Monoclonal antibodies, Biology, Life sciences, Aducanumab, Amyloid beta, Accelerated approval, Indication, Amyloid, Biogen

There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Key Points: 
  • There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
  • This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.
  • Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
  • Several of these relationships were not apparent in ENGAGE, in which a clinical treatment effect of aducanumab was not observed.

Eisai: FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

Retrieved on: 
Friday, July 23, 2021
Medicine, Health sciences, Cancer treatments, Antineoplastic drugs, Orphan drugs, Cancer immunotherapy, Breakthrough therapy, Pharmaceutical industry, Pembrolizumab, Eisai, Accelerated approval, Corticosteroid

Based on the type and/or severity of the adverse reaction, LENVIMA may be interrupted, reduced and/or discontinued.

Key Points: 
  • Based on the type and/or severity of the adverse reaction, LENVIMA may be interrupted, reduced and/or discontinued.
  • Based on its mechanism of action and data from animal reproduction studies, LENVIMA can cause fetal harm when administered to a pregnant woman.
  • Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate.
  • "Based on Phase 3 data, today's approval acts as the confirmatory trial to our previous accelerated approval of KEYTRUDA plus LENVIMA in patients with certain types of advanced endometrial cancer and reinforces the impact of our joint research with Eisai in exploring the potential of this combination to treat more patients with challenging types of cancer."

Cend Therapeutics’ CEND-1 Granted Fast Track Designation for Pancreatic Cancer

Retrieved on: 
Tuesday, June 29, 2021
Food and Drug Administration, Clinical medicine, Medicine, Orphan drugs, Drugs, Antineoplastic drugs, Peptides, iRGD, Accelerated approval, Pancreatic cancer, Fast track, Priority review

CEND-1 was granted Orphan Drug Designation by the FDA for the treatment of pancreatic cancer in January 2019.

Key Points: 
  • CEND-1 was granted Orphan Drug Designation by the FDA for the treatment of pancreatic cancer in January 2019.
  • By awarding Fast Track Designation, the FDA has recognized CEND-1s potential to meaningfully improve outcomes for pancreatic cancer patients,said Andrew Dorr, MD, Chief Medical Officer of Cend.
  • Fast Track designation can lead to an Accelerated Approval and Priority Review if certain criteria are met.
  • Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patients immune system and immunotherapies to more effectively fight cancer.

Applied Therapeutics Granted Fast Track Designation by FDA for AT-007 for Galactosemia

Retrieved on: 
Thursday, June 17, 2021
Life sciences, Food and Drug Administration, Health, Fast track, Galactosemia, Orphan drug, Accelerated approval, PMM2 deficiency, Priority review

Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process.

Key Points: 
  • Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process.
  • Applied Therapeutics plans to submit an NDA for Accelerated Approval of AT-007 for the treatment of Galactosemia in the third quarter of this year.
  • FDA has previously granted Orphan Drug Designation and Pediatric Rare Disease status to AT-007 for Galactosemia.
  • AT-007 has received both Orphan Drug and Pediatric Rare Disease designations from the U.S. Food and Drug Administration (FDA) for the treatment of Galactosemia and PMM2-CDG, and Fast Track designation for Galactosemia.

Multi-Site Contributor Headlands Research Congratulates Biogen on FDA Approval of Aducanumab for Alzheimer’s Disease

Retrieved on: 
Wednesday, June 16, 2021
Health sciences, Health, Life sciences, Food and Drug Administration, Pharmaceutical industry, Monoclonal antibodies, Aducanumab, Biogen, Amyloidosis, Alzheimer's disease, Accelerated approval, Clinical trial

SAN FRANCISCO, June 16, 2021 (GLOBE NEWSWIRE) -- Headlands Research ( www.headlandsresearch.com ), a global next-generation clinical research site organization, is pleased to have supported Biogen with its efforts to obtain FDA accelerated approval of Aducanumab for Alzheimers disease.

Key Points: 
  • SAN FRANCISCO, June 16, 2021 (GLOBE NEWSWIRE) -- Headlands Research ( www.headlandsresearch.com ), a global next-generation clinical research site organization, is pleased to have supported Biogen with its efforts to obtain FDA accelerated approval of Aducanumab for Alzheimers disease.
  • Headlands contributed to the development of Aducanumab at three of its clinical trial sites: Toronto Memory Program (Toronto, Ontario), JEM Research Institute (Lake Worth, Florida), and Summit Research (Portland, Oregon).
  • Alzheimers disease is the sixth-leading cause of death in the United States and obtaining FDA approval for Aducanumab ends a more than two-decade drought for additional Alzheimer disease treatment options, said Mark Blumling, CEO and Founder of Headlands Research.
  • Headlands Researchs clinical research contributions to the develop of Aducanumab spanned two countries and four different principal investigators.

FDA grants accelerated approval for ADUHELM as the first and only Alzheimer's disease treatment to address a defining pathology of the disease

Retrieved on: 
Tuesday, June 8, 2021
Life sciences, Health sciences, Health, Abnormal psychology, Alzheimer's disease, Amyloidosis, Aphasias, Dementia, Biogen, Accelerated approval, Aducanumab, Latrepirdine

Continued approval for ADUHELM's indication as a treatment for Alzheimer's disease may be contingent upon verification of clinical benefit in confirmatory trial(s).

Key Points: 
  • Continued approval for ADUHELM's indication as a treatment for Alzheimer's disease may be contingent upon verification of clinical benefit in confirmatory trial(s).
  • "This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer's disease.
  • "We are very pleased to be able to open a new chapter in the history of Alzheimer's disease treatment with the approval of ADUHELM.
  • As part of the accelerated approval, Biogen will conduct a controlled trial to verify the clinical benefit of ADUHELM in patients with Alzheimer's disease.

FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease

Retrieved on: 
Monday, June 7, 2021
Monoclonal antibodies, Branches of biology, Life sciences, Drugs, Amyloidosis, Aducanumab, Treatment of Alzheimer's disease, Alzheimer's disease, Biogen, Amyloid beta, Accelerated approval, Donanemab

Continued approval for ADUHELMs indication as a treatment for Alzheimers disease may be contingent upon verification of clinical benefit in confirmatory trial(s).

Key Points: 
  • Continued approval for ADUHELMs indication as a treatment for Alzheimers disease may be contingent upon verification of clinical benefit in confirmatory trial(s).
  • We are very pleased to be able to open a new chapter in the history of Alzheimers disease treatment with the approval of ADUHELM.
  • As part of the accelerated approval, Biogen will conduct a controlled trial to verify the clinical benefit of ADUHELM in patients with Alzheimers disease.
  • ADUHELM (aducanumab-avwa), a human monoclonal antibody, is the first and only Alzheimers disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain.

FDA Grants Accelerated Approval for Alzheimer's Drug

Retrieved on: 
Monday, June 7, 2021
Health sciences, Health, Life sciences, Food and Drug Administration, Medical statistics, Clinical trials, Pharmaceutical industry, Medical terminology, Accelerated approval, Surrogate endpoint, Fast track, Breakthrough therapy

Aduhelm was approved using the accelerated approval pathway , which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

Key Points: 
  • Aduhelm was approved using the accelerated approval pathway , which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.
  • Accelerated approval can be based on the drug's effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.
  • As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation."
  • If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.

Epizyme Announces Date of First Quarter 2021 Financial Results

Retrieved on: 
Thursday, April 29, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Medicine, Health sciences, Orphan drugs, Health, Food and Drug Administration, Pharmaceutical industry, Cancer treatments, Accelerated approval, Indication, Tazemetostat

These indications are approved under accelerated approval based on overall response rate and duration of response.

Key Points: 
  • These indications are approved under accelerated approval based on overall response rate and duration of response.
  • Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them.
  • For more information, visit www.epizyme.com .\nTAZVERIK\xc2\xae is a registered trademark of Epizyme, Inc.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210429005135/en/\n"

Protalix BioTherapeutics Provides Update on Complete Response Letter for Pegunigalsidase Alfa from the FDA

Retrieved on: 
Wednesday, April 28, 2021
Protalix BioTherapeutics, Companies, Food and Drug Administration, Accelerated approval, Health care, Health

Due to travel restrictions, the FDA was unable to conduct the required inspection during the review cycle.

Key Points: 
  • Due to travel restrictions, the FDA was unable to conduct the required inspection during the review cycle.
  • Protalix intends to work collaboratively with the agency to identify the most expeditious pathway to approval, including accelerated approval.
  • Protalix remains confident that it will be able to work with the FDA to resolve these issues and provide a new, alternative drug to Fabry patients.
  • Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system.