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The Quinze-Vingts Hospital and GenSight Biologics Announce a First Temporary Authorization for Use (ATU) for LUMEVOQ (GS010) in France

Nachrichtenquelle: Business Wire (engl.)
09.12.2019, 07:30  |  113   |   |   

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191208005050/en/

The National Eye Hospital (CHNO) of the Quinze-Vingts in Paris and GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the French Competent Authority, the National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM), granted a named patient Temporary Authorization for Use (“ATU nominative”) for LUMEVOQ (GS010) to the CHNO of the Quinze-Vingts. Dr Catherine Vignal, who as the prescribing physician originated the request, will be able to use LUMEVOQ to treat a patient recently affected by Leber Hereditary Optic Neuropathy (LHON). GenSight Biologics committed to provide the drug for a bilateral injection.

As we are preparing to file for Marketing Approval in Europe in 2020, this ATU testifies to the strong interest of the medical community for LUMEVOQ and to the impact on patients,” said Bernard Gilly, Co-founder and Chief Executive Officer of GenSight. “We are of course willing to provide available products if more requests are authorized.”

Leber Hereditary Optic Neuropathy (LHON) is a rare, maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in precipitous and irreversible vision loss typically leading to legal blindness. The disease mainly affects adolescents and young adults. LHON is associated with painless, dramatic and sudden loss of central vision in the first eye, with the second eye becoming irreversibly involved shortly after. 97% of patients have bilateral involvement within one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. LHON causes the blindness of an estimated 1,400 to 1,500 new patients each year in the United States and Europe.

France’s ATU program is a powerful means of providing LHON patients with the ND4 mutation, with a therapeutic solution, LUMEVOQ gene therapy,” said Dr. Catherine Vignal, Principal Investigator for LUMEVOQ trials at the Department of Ophthalmology at Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (Department led by Dr José-Alain Sahel) and Head of the department of Neuro-Ophthalmology at the Rothschild Foundation, Paris. “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.”

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