Bayer: FDA Fast Track designation for Parkinson's treatment
(CercleFinance.com) - AskBio has received FDA Fast Track designation for its investigational GDNF gene therapy AB-1005 for Parkinson's disease.
The FDA's Fast Track program is designed to facilitate the development and accelerate the review of new therapeutic products to treat serious diseases and address unmet medical needs.
AB-1005 has also received the Innovation Passport, the UK Medicines and Healthcare products Regulatory Agency's (UK MHRA) Innovative Medicines Designation, for this treatment.
AB-1005 (formerly known as AAV2-GDNF) is being studied for the treatment of patients with moderate Parkinson's disease. AskBio is currently enrolling patients in its Phase II REGENERATE-PD trial in the US.
These designations clearly underscore the importance of developing innovative therapies for people living with Parkinson's disease, where there is still a significant unmet need, AskBio said.
It adds that they further underscore the willingness of key regulatory bodies to support the accelerated development of AB-1005 with a focus on the potential benefit to patients.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The FDA's Fast Track program is designed to facilitate the development and accelerate the review of new therapeutic products to treat serious diseases and address unmet medical needs.
AB-1005 has also received the Innovation Passport, the UK Medicines and Healthcare products Regulatory Agency's (UK MHRA) Innovative Medicines Designation, for this treatment.
AB-1005 (formerly known as AAV2-GDNF) is being studied for the treatment of patients with moderate Parkinson's disease. AskBio is currently enrolling patients in its Phase II REGENERATE-PD trial in the US.
These designations clearly underscore the importance of developing innovative therapies for people living with Parkinson's disease, where there is still a significant unmet need, AskBio said.
It adds that they further underscore the willingness of key regulatory bodies to support the accelerated development of AB-1005 with a focus on the potential benefit to patients.
Copyright (c) 2024 CercleFinance.com. All rights reserved.