Understand the Approval of Elevidys and How QR Group Assists® in the Registration Process of Innovative Products in Brazil
The approval of Elevidys® (delandistrogen moxeparvoveque) by ANVISA for the treatment of Duchenne Muscular Dystrophy (DMD) represents a milestone in the area of advanced therapies in Brazil. QR Group, with its expertise in medical device and drug regulation, can help companies navigate ANVISA’s demanding requirements and ensure the compliance of their products. In this article, we explore the approval of Elevidys® and the impact of this new gene therapy on the Brazilian market.
Impacts of Elevidys® Approval for DMD in Brazil
Duchenne muscular dystrophy (DMD) is a rare and progressive disease that causes the deterioration of muscles and mainly affects children. With the approval of Elevidys®, ANVISA paves the way for innovative treatments in Brazil, offering new alternatives for a condition that, until then, had limited therapeutic options. Elevidys® is the first gene therapy drug approved in Brazil for the treatment of children 4 to 7 years of age with DMD, a victory for ambulatory children, who are still able to walk.
How QR Group Assists in the Advanced Therapies Registration Process
The process of registering advanced therapies in Brazil can be complex and challenging. QR Group, a specialist in health product regulation, helps international companies register their products with ANVISA with ANVISA with efficiency and agility. The approval of Elevidys® was possible thanks to a priority technical process by ANVISA, which evaluated the safety and efficacy of the product based on clinical studies and data from non-clinical trials. QR Group supports companies in complying with all regulatory requirements, facilitating access to new treatments in the Brazilian market.
RDC 505/2021 and the Exceptional Registration of Elevidys®
Elevidys® was registered by ANVISA on an exceptional basis, according to article 30 of Collegiate Board Resolution (RDC) 505/2021, a regulation that allows the approval of drugs for rare and serious diseases. RDC 505/2021 establishes that, in cases of unmet clinical need and with evidence of efficacy, ANVISA can grant product registrations under continuous monitoring. This process aims to ensure that innovative drugs like Elevidys® reach patients who need it most, without compromising safety.
QR Group’s Role in Regulatory Compliance of Innovative Medicines
QR Group has a key role in guiding companies through the regulatory process for medicines like Elevidys®. The company ensures that its customers meet ANVISA’s requirements, such as stability studies, product quality, and post-approval monitoring, in addition to ensuring that all safety requirements are met. With QR Group’s expertise, companies can focus on bringing innovations to the Brazilian market, while leaving the regulatory part in the care of qualified professionals.
Post-Approval Monitoring and Commitments with ANVISA
After the approval of Elevidys®, ANVISA established a Term of Commitment with the company Produtos Roche Químicos e Farmacêuticos S.A., which includes the performance of long-term follow-up studies. QR Group can help companies understand the implications of these commitments and ensure that post-approval monitoring is carried out in accordance with ANVISA’s requirements. This includes the collection of additional data on safety and efficacy, which are essential for the continuity of product registration.
Ensuring Success in Health Product Registration
The approval of Elevidys® is a clear example of the evolution of the advanced therapies sector in Brazil, and QR Group is ready to help international manufacturers navigate regulatory challenges. If your company wants to register an innovative product in Brazil, contact QR Group. Our expertise in regulation and compliance processes with ANVISA ensures that you are always ahead, meeting all requirements in an agile and efficient way.
If your company is ready to register an innovative health product in Brazil, contact QR Group and ensure regulatory compliance with ANVISA. We are here to facilitate your registration process and ensure the success of your entry into the Brazilian market.
Source: ANVISA
