ANSEM (the National Agency for Medicines and Health Products Safety), France’s Competent Authority, has granted Cohort Temporary Authorization for Use (ATUc) to GenSight Biologic’s LUMEVOQ®. LUMEVOQ® is a drug therapy designed to treat Leber Hereditary Optic Neuropathy (LHON), a rare, inherited mitochondrial disease brought on from ND4 gene mutation that can leads to vision loss. Co-founder and CEO of GenSight, Bernard Gelly, stated, “The decision of the French ANSM to authorize LUMEVOQ to be administered under a Cohort ATU will facilitate early access to treatment for patients with LHON and indeed attests to the safety and efficacy of LUMEVOQ. The compassionate use and expanded access programs already running in Europe and the US will also allow GenSight to collect additional data that will bolster the already impressive evidence on LUMEVOQ’s clinical benefit and the safety profile and support our drive to obtain marketing authorization in Europe and North America.”
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