SILVER SPRING
Adrabetadex NDA review period extended
- Sponsor
- Beren Therapeutics
- Drug
- adrabetadex
- Indication
- Infantile-onset Niemann-Pick disease, type C
FDA extends the review period for Beren Therapeutics' NDA for adrabetadex in infantile-onset Niemann-Pick disease type C.
What this means
Adrabetadex is an experimental drug designed to treat a rare, fatal genetic disorder in children called Niemann-Pick disease type C. The FDA has extended its review period for the drug's application by three months, giving the agency more time to evaluate the data. This means a decision on whether the treatment can be approved for use is now expected later this year.