Sun Pharmaceutical gets SEZABY FDA approval for neonatal seizures

Sun Pharmaceutical Industries has secured approval for SEZABY (phenobarbital sodium powder for injection) from the US Food and Drug Administration (FDA) for the treatment of neonatal seizures.

According to Sun Pharmaceutical, the approval makes SEZABY the first and only product to be indicated specifically in the US for treating neonatal seizures in term and preterm infants.

The Indian pharma company expects to launch SEZABY in the US in the fourth quarter of FY23.

Commenting on SEZABY FDA approval, Abhay Gandhi — Sun Pharmaceutical North America CEO said: “SEZABY is an exciting addition to our growing portfolio of specialty branded products in the U.S.

“As the first and only product specifically indicated to treat seizures in term and preterm infants, SEZABY has the potential to make a difference in the lives of patients and their families.”

SEZABY, which is a formulation of phenobarbital sodium powder for injection, was given orphan drug designation by the FDA in neonatal seizures.

Licensed recently by Sun Pharma Advanced Research Company (SPARC) to Sun Pharmaceutical, the drug is benzyl alcohol-free and propylene glycol-free. As per the terms of the licensing deal, SPARC is entitled to get a milestone payment on FDA approval of SEZABY.

Anil Raghavan — SPARC CEO said: “For years, physicians have had limited treatment options to manage neonates with seizures. SPARC is proud to have developed benzyl alcohol-free and propylene glycol-free phenobarbital sodium powder for injection as the first treatment option now approved by the US FDA.”

SEZABY FDA approval was driven by the findings of the NEOLEV2 phase 2 clinical trial that assessed levetiracetam in comparison to phenobarbital in the first-line setting for neonatal seizures. Twenty-four hours after giving phenobarbital or levetiracetam, 73% vs. 25% were seizure-free in the respective arms of the clinical trial that featured a total of 94 neonates.