Regulators in the USA have approved a new epilepsy drug, Aptiom, which will be marketed by Dainippon Sumitomo Pharma unit Sunovion Pharmaceuticals.
The US Food and Drug Administration has given the green light to Aptiom (eslicarbazepine acetate), for use as adjunctive treatment of partial-onset seizures. The approval is based on three large Phase III trials, jointly performed with Portugal’s Bial, included more than 1,400 people inadequately controlled by one to three anti-epileptic drugs (including carbamazepine, lamotrigine, valproic acid and levetiracetam).
Eric Bastings, acting director of the FDA’s Division of Neurology Products, said that “some patients with epilepsy do not achieve satisfactory seizure control from existing treatments. It is important we continue to make new treatment options available”. Sunovion expects Aptiom to be available in US pharmacies in the second quarter of 2014.
Sunovion acquired the North American rights to Aptiom from Bial which licensed the drug in Europe to Eisai. It was approved by the European Commission in April 2009 and is sold as Zebinix.
Generic Aciphex approved
Meantime, the FDA has approved the first generic versions of Eisai’s Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD). The companies that have been given the rights to sell their copes of the proton-pump inhibitor are a number of India-headquartered firms – Dr Reddy’s, Lupin and Torrent – as well as Teva, Mylan and UCB’s Kremers Urban.
In response, Eisai has launched a sprinkle formulation of Aciphex in the USA which it says represents a new treatment option for young children who suffer from GERD.
