Diamond Supports GenSight Biologics in LUMEVOQ MAA Submission
5th October 2020
- Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ
- LUMEVOQ is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary Optic Neuropathy
Harlow, Essex, UK, 05 October 2020 – Diamond Pharma Services (“Diamond”), a leading technical services and regulatory affairs consulting group, has announced that it provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight Biologics (“GenSight”), including the preparation, authoring support, agency communication and submission of GenSight’s first Marketing Authorisation Application to the European Medicines Agency (EMA), for its novel ocular gene therapy LUMEVOQ®. The EMA decision is expected in H2 2021.
LUMEVOQ (Lenadogene nolparvovec) is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary Optic Neuropathy (LHON) caused by mutation in the ND4 mitochondrial gene. LHON mainly affects young males, and the ND4 mutation results in the worst visual outcomes, with most patients becoming legally blind. There is a high unmet medical need for LHON patients, of which there are 800-1200 in the EU and the US annually.
Headquartered in Paris, France, GenSight is a biopharma company focused on developing and commercialising innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. Diamond has provided GenSight with regulatory, pharmacovigilance, quality and compliance support for LUMEVOQ leading up to the MAA assessment.
Maureen Graham, Managing Director, Regulatory, Diamond Pharma Services, said:
“We are pleased GenSight Biologics chose to work with our team of experts at Diamond to provide European Regulatory, Pharmacovigilance, Quality and Compliance support for LUMEVOQ, its first MAA submission, and the first for a gene therapy treating a mitochondrial disease. It has been a personal ambition of mine to have the opportunity to work on a gene therapy within the ophthalmic arena, and GenSight has allowed Diamond that opportunity and that privilege.
This submission adds to Diamond’s broad experience in providing support to companies developing advanced therapy medicinal products (ATMPs), which includes over 50 programmes at various stages of development, and two MAA approvals - Glybera® and Yescarta®.”
For further information, please contact:
Tel: +44 7787 502 947
Notes to Editors
About Diamond Pharma Services
Diamond Pharma Services (“Diamond”) is a regulatory affairs and product development consultancy headquartered in the UK, with offices in Europe as well as a US subsidiary. Diamond’s skilled team of qualified regulatory professionals has many years’ experience in regulatory, pharmacovigilance, compliance and quality, and pharmaceutical/biologics technical development. Diamond provides support from early stage development through to life cycle management of approved products, across all therapeutic areas, medicinal products, and devices, including small molecule and next generation biologics, through to cell and gene therapy products.
Diamond has been twice recognised by TOPRA (The Organisation for Professionals in Regulatory Affairs), for excellence and innovation in EU regulatory affairs.