Court rules Sun Pharma should have received a priority review voucher for Sezaby in 2022
Sun Pharma was denied a Priority Review Voucher in 2022 following FDA approval of Sezaby (phenobarbital sodium) for neonatal seizures. They sued the FDA last year, and yesterday a District Court ruled in their favor.
To be eligible for a rare disease priority review voucher, the New Drug Application (NDA) must seek approval for a drug that contains no active moiety that has been previously 'approved' in any other application. A tablet containing phenobarbital and atropine was submitted in 1939 (NDA 000597). At the time, an NDA would become automatically effective unless a specific order to deny/refuse was issued.
In 1962, Congress now required formal agency approval based on substantial evidence that the drug is effective. For products that were previously automatically effective, such as the 1939 tablet, they were 'deemed approved' and given a 2yr grace period. After the 2yr grace period, the FDA could remove the drug from the market if it did not have substantial evidence of effectiveness. The 1939 drug was eventually withdrawn due to lack of an evidence submission.
The arguments from Sun Pharma and the FDA/HHS were centred around whether a drug that was 'deemed approved' is the same as a drug that is 'approved'. Ultimately, the court ruled that the historic NDA 000597 was not a previously 'approved' application and thus a Priority Review Voucher for Sezaby should have been issued to Sun Pharma in 2022. The FDA can appeal the court decision should they wish to.
