Date: 2018-08-16
Type of
information: Submission of a clinical trial application
phase: 1
Announcement: submission of a clinical trial application
Company: Editas Medicine (USA - MA)
Product: EDIT-101
Action
mechanism:
- genome editing product. In August 2018, Allergan exercised its option to develop and commercialize EDIT-101 globally for the treatment of LCA10. Additionally, Editas Medicine has exercised its option to co-develop and share equally in the profits and losses from EDIT-101 in the United States .
Disease: Leber congenital amaurosis type 10 (LCA10)
Therapeutic
area: Rare diseases - Genetic diseases - Ophtalmological diseases
Country: USA
Trial
details:
Latest
news:
- • On August 16, 2018, Editas Medicine announced that the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) completed the NIH protocol registration process for EDIT-101. The NIH determined a public meeting is not necessary, and the RAC will not be convened to review this clinical trial.
- Editas Medicine plans to file an Investigational New Drug (IND) application with the FDA in October.
Is
general: Yes
