The U.S Food and Drug Administration on Thursday approved Zogenix Inc's drug to treat seizures associated with a rare form of childhood epilepsy known as Dravet syndrome.
The drug, branded as Fintepla, uses a low-dose liquid solution of fenfluramine, which was used in an obesity drug combination that was later withdrawn from the market due to evidence of heart valve damage.
The approval contains a boxed warning, the FDA's harshest, flagging concerns about valvular heart disease and pulmonary arterial hypertension, and is available only through a restricted drug distribution program. (https://reut.rs/3g2naBs)
The agency last year had refused to fully review the marketing application for the treatment, and in February extended the application's review by three months.
Dravet Syndrome, which affects about 1 in 15,700 individuals in the United States, causes long and frequent seizures that are difficult to control through antiepileptic medicines.
The approval pits Zogenix against GW Pharmaceutical's cannabis-based drug, Epidiolex, which is also approved to treat seizures related to Dravet Syndrome and Lennox-Gastaut syndrome.
Fintepla is expected to bring in peak sales of about $450 million in about 5-7 years for its use against Dravet syndrome, according to Guggenheim analyst Yatin Suneja.
Zogenix is also testing Fintepla for treating Lennox-Gastaut syndrome.
(Reporting by Manas Mishra, Manojna Maddipatla and Trisha Roy in Bengaluru; editing by Uttaresh.V)
