On 19 January, UCB announced that it had acquired Zogenix for $1.9bn in a bid to bolster its epilepsy portfolio by adding Fintepla (fenfluramine), a marketed drug for the treatment of seizures associated with Dravet syndrome, a rare form of childhood epilepsy. Having gained a newly marketed product for patients with rare and difficult-to-treat pediatric orphan epilepsy syndromes, this deal continues to expand UCB’s extensive therapeutic offering in the epilepsy market.

With the acquisition of Zogenix, UCB has obtained Fintepla, an FDA and EMA-approved drug for the treatment of seizures associated with Dravet syndrome. A new drug application for Fintepla was submitted in Japan last month, with the drug estimated to receive approval and launch later this year. The use of Fintepla is soon anticipated to expand beyond Dravet syndrome and to include Lennox-Gastaut syndrome (LGS), another severe form of epilepsy in children and adults. The FDA has accepted the supplemental new drug application for Fintepla in LGS and has granted priority review for the submission, with a Prescription Drug User Fee Act target action date of 25 March. In addition, a type II variation application has been submitted to the EMA for the use of Fintepla in LGS. The drug is currently in a Phase III clinical trial in Japan for LGS, with a primary completion date of March 2024 (NCT03355209). Fintepla is also being investigated in an ongoing Phase III trial for the treatment of patients with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder, which is characterised by seizures that begin in infancy. The trial is being conducted in the US, with a primary completion date of May next year (NCT05064878).

Fintepla competes with GW Pharmaceuticals’ Epidiolex (cannabidiol), which is approved for both LGS and Dravet syndrome. Not only does Epidiolex have a first-to-market advantage, but, as a cannabidiol-derived drug, it also has strong patient interest based on its ‘natural’ plant-derived sourcing. Despite this, key opinion leaders previously interviewed by GlobalData were impressed with the efficacy of Fintepla in paediatric patients with severe forms of epilepsy, many of whom have experienced seizures for many years. But concerns over cardiac safety could represent a barrier to uptake of Fintepla. At present, the prescription of Fintepla in the US is only available through a restricted risk evaluation and mitigation strategy programme, which is designed to manage the risks of valvular heart disease and pulmonary arterial hypertension associated with treatment. As such, echocardiogram assessments and monitoring are required before, during and after treatment. With the growing availability of products for patients with Dravet syndrome and LGS, Phase IV head-to-head clinical trials will be the key to differentiating products from one another. 

UCB has become a major player in the epilepsy market, owing to its wide variety of marketed assets launched between 2000 and 2019: Keppra, Keppra XR, Briviact, Vimpat and Nayzilam. In addition, through its acquisition of Engage Therapeutics in June 2020, UCB gained the pipeline anti-epileptic product, Staccato Alprazolam, which is now in Phase III clinical trials for the acute treatment of patients aged 12 years and older with prolonged epileptic seizures (NCT05077904). The clinical trial is being conducted in locations across the US and Japan and its primary completion date is set for July next year. UCB’s strong pipeline, coupled with the company’s vast experience in the epilepsy market, strongly indicate the company will remain a major player in the epilepsy market in the next decade and beyond.

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