From OSN Europe

GenSight’s LHON treatment receives French temporary authorization for use

A patient at France’s National Eye Hospital of the Quinze-Vingts has been granted temporary authorization for use of Lumevoq, GenSight Biologics’ gene therapy for the treatment of Leber hereditary optic neuropathy, according to a press release.

Lumevoq, also known as GS010, targets LHON by leveraging a mitochondrial targeting sequence proprietary technology platform, which addresses defects in the mitochondria using an adeno-associated virus vector.

The French Competent Authority’s temporary authorization program allows a product not yet approved with a marketing authorization and not recruiting for clinical trials to be used in patients if it is meant to treat, prevent or diagnose a severe or rare disease that has no other treatment.

“France’s ATU program is a powerful means of providing LHON patients with the ND4 mutation with a therapeutic solution, Lumevoq gene therapy,” Catherine Vignal, MD, principal investigator for Lumevoq trials at the department of ophthalmology at Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts and head of the department of neuro-ophthalmology at the Rothschild Foundation, Paris, said in the release. “To me as a clinician, it is important that I can now offer my patients a treatment for their condition, in close collaboration with the Regulatory Competent Authorities, while waiting for official marketing authorization.”

A patient at France’s National Eye Hospital of the Quinze-Vingts has been granted temporary authorization for use of Lumevoq, GenSight Biologics’ gene therapy for the treatment of Leber hereditary optic neuropathy, according to a press release.

Lumevoq, also known as GS010, targets LHON by leveraging a mitochondrial targeting sequence proprietary technology platform, which addresses defects in the mitochondria using an adeno-associated virus vector.

The French Competent Authority’s temporary authorization program allows a product not yet approved with a marketing authorization and not recruiting for clinical trials to be used in patients if it is meant to treat, prevent or diagnose a severe or rare disease that has no other treatment.

“France’s ATU program is a powerful means of providing LHON patients with the ND4 mutation with a therapeutic solution, Lumevoq gene therapy,” Catherine Vignal, MD, principal investigator for Lumevoq trials at the department of ophthalmology at Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts and head of the department of neuro-ophthalmology at the Rothschild Foundation, Paris, said in the release. “To me as a clinician, it is important that I can now offer my patients a treatment for their condition, in close collaboration with the Regulatory Competent Authorities, while waiting for official marketing authorization.”