UCB has won FDA approval for Fintepla as a treatment seizures associated with rare childhood epilepsy Lennox-Gastaut Syndrome (LGS), raising the pressure on Jazz Pharma’s rival therapy Epidiolex.
Fintepla (fenfluramine) – acquired by UCB when it completed its $2 billion takeover of Zogenix earlier this month – is already approved by the FDA to treat Dravet syndrome, another of Epidiolex’ approved indications.
Belgium-based UCB reckons Fintepla has blockbuster potential, and it has a lot riding on the drug’s success given that its $1.6 billion epilepsy therapy Vimpat (lacosamide) is now facing the threat of generic competition in the US.
UCB reckons that there are between 30,000 and 50,000 people in the US with LGS, which is currently treated with a range of standard anticonvulsant therapies as well as Epidiolex (cannabidiol), which accounted for $464 million of Jazz’s total sales of $3.1 billion last year.
The FDA has approved Fintepla for LGS in patients aged two years of age and older, and UCB says it will make the drug available through a restricted distribution programme designed to ensure its safe use.
Fenfluramine achieved some degree of notoriety in the 1990s as half of the fen-phen weight-loss therapy, which was banned after a link emerged to cardiovascular disease including heart valve problems. Fintepla includes fenfluramine at a lower dose and there hasn’t been any evidence of cardiovascular problems in clinical trials, according to Zogenix.
Fintepla is a key element of UCB’s plans to defend its epilepsy franchise, which also includes $1 billion blockbuster Keppra (levetiracetam) as well as Briviact (brivaracetam) and Nayzilam (midazolam), which brought in $390 million and $63 million last year, respectively.
UCB also added to its epilepsy pipeline in 2020 when it bought Engage Therapeutics and its inhaled version of alprazolam, in phase 3 trials as an acute treatment for seizures, for $125 million upfront.
Along with LGS and Dravet, UCB is also developing Fintepla for CDKL5 deficiency disorder, another rare form of epilepsy that is also being investigated as a potential use for Epidiolex.
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