UCB says that Europe’s Committee for Orphan Medicinal Products has recommended granting orphan drug status to the Belgian company’s brivaracetam in the treatment of progressive myoclonic epilepsies – a form of epilepsy caused by rare disorders.
Orphan medicinal products are used to diagnose, prevent or treat life-threatening or very serious conditions that are rare, with a prevalence of less than five per 10,000 of the EU population. European orphan drug designation enables companies to receive regulatory guidance in the drug development process and allows for up to 10 years’ of European market exclusivity for the designated indication upon approval of the market application.
Brivaracetam is the follow-up to UCB’s top-selling epilepsy offering, Keppra (levetiracetam). It has shown significant anti-epileptic activity in animal models of epilepsy, both in vitro and in vivo, as well as in a photosensitive epilepsy model in humans and is currently being evaluated for the treatment of refractory patients with partial onset seizures.