J&J gene therapy nabs accelerated review status in Europe for vision loss disorder

The European Medicines Agency has granted PRIME and Advanced Therapy Medicinal Product designations to Johnson & Johnson (JNJ +1.9%) unit Janssen Pharmaceutical Companies’ AAV-RPGR gene therapy for the treatment of X-linked retinitis pigmentosa, an inherited eye disorder that causes progressive vision loss in boys and young men.

The company is developing the candidate with licensor MeiraGTx Holdings (MGTX +5.2%).

PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.

Advanced Therapy Medicinal Product status allows for, among other things, centralized regulatory approval based on a single clinical trial.

https://seekingalpha.com/news/3547547-j-and-j-gene-therapy-nabs-accelerated-review-status-in-europe-for-vision-loss-disorder