Valoctocogene Roxaparvovec

Form: Intravenous infusion

Strength: A single-dose gene therapy designed to increase factor VIII production in hemophilia A patients

Reference Brands: Roctavian(US & EU)

Category: Cell & Gene Therapies

Valoctocogene roxaparvovec (Roctavian) is regulated in the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involved extensive clinical trials and safety assessments, while in the EU, regulatory review is ongoing, with CE marking anticipated. These gene therapies undergo validation, stability testing, and audits, supported by detailed documentation, including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to innovative, long-lasting gene therapy treatments for hemophilia A worldwide, supporting improved patient outcomes and advanced healthcare.