FDA extends Prescription Drug User Fee Act date for macular telangiectasia type 2 therapy
Key takeaways:
- NT-501 is an encapsulated cell therapy for macular telangiectasia type 2.
- The new Prescription Drug User Fee Act date is March 18, 2025.
The FDA has extended its Prescription Drug User Fee Act date for the biologics license application for NT-501, a treatment for macular telangiectasia type 2, according to a press release from Neurotech Pharmaceuticals.
The new date for NT-501 (revakinagene taroretcel), an encapsulated cell therapy, is March 18, 2025. The FDA requested more time to review additional data provided by Neurotech.
“We are committed to providing the agency any information needed to complete the review of the NT-501 BLA,” Richard Small, CEO of Neurotech, said in the press release. “Neurotech will continue in our effort to bring this important therapy to [macular telangiectasia type 2] patients."
As Healio previously reported, two parallel phase 3 trials of NT-501 met the primary outcome of ellipsoid zone loss, which was measured using OCT.
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