Paris, France, April 14, 2022, 7:30 am CEST – GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma Company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) has granted the Company a six-month extension for submitting its responses to the Day 120 questions in the regulatory review of LUMEVOQ®, GenSight’s gene therapy for the treatment of Leber Hereditary Optic Neuropathy (LHON).
The Company requested the extension in order to implement process adjustments in the manufacturing of the validation (PPQ) batches required for marketing approval (GenSight Biologics Provides Update on LUMEVOQ® Manufacturing Timeline – GenSight Biologics (gensight-biologics.com). The Company is working with its manufacturing partner to implement targeted corrections around enhanced process control and more rigorous supervision inside the manufacturing suites. In addition, smaller engineering lots will be used to confirm the robustness of the corrective actions.
GenSight targets the restart of the PPQ campaign in Q3 2022. In the meantime, the Company has already finalized the responses to the D120 questions that were not related to the validation batches.
Responses to the Day 120 questions are now due in October 2022, after which regulatory review of LUMEVOQ®’s Marketing Authorisation Application will resume. The Company expects the opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) by Q3 2023, to be followed by commercial launch by the end of 2023.
“We are highly appreciative and grateful for the flexibility that the CAT has shown during the review of LUMEVOQ’s regulatory filing,” commented Bernard Gilly, Chief Executive Officer and Co-Founder of GenSight Biologics. “The additional time granted allows us to implement the necessary adjustments with our manufacturing partner to ensure that LUMEVOQ is reliably and consistently produced at the scale needed for the upcoming commercial launch. These measures are part of our commitment to providing LHON patients with access to our innovative treatment as soon as possible.”
“It is worth reiterating that the necessary adjustments are not related to any efficiency or safety issue linked to our gene therapy”, added Bernard. “The soundness of the manufacturing process itself was never in doubt, as it had already generated product at the highest quality and safety needed for our clinical trials and compassionate use.”
In parallel, GenSight is continuing to work on making its product available in the United States. In line with recent announcements (e.g., GenSight Biologics Reports Cash Position as of December 31, 2021, and Provides Operational Update – GenSight Biologics (gensight-biologics.com), the Company is preparing to move forward quickly with a new clinical trial when product from the validation runs becomes available.
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