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November 10, 2013

Sunovion’s Aptiom gets US approval for once-daily adjunctive treatment of partial-onset seizures

Sunovion Pharmaceuticals (Sunovion), a US-based subsidiary of Japanese drugmaker Dainippon Sumitomo Pharma, has received approval from the US Food and Drug Administration (FDA) for its anti-epileptic drug (AED) to be sold under the brand name Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures.

By admin-demo

Sunovion Pharmaceuticals (Sunovion), a US-subsidiary of Japanese drugmaker Dainippon Sumitomo Pharma, has received approval from the US Food and Drug Administration (FDA) for its anti-epileptic drug (AED) to be sold under the brand name Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures.

Aptiom is indicated for the treatment of partial seizures, which is the most common type in people with epilepsy.

FDA said that seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior and generalised convulsions with loss of consciousness as well as it can have serious consequences, including injury and death.

According to the Centers for Disease Control and Prevention, epilepsy is one of the most common neurological disorders and affects about 2.2 million people in the US, while partial-onset seizures are the most prevalent seizure type, which account for 60% of new epilepsy diagnoses.

Bial, a Portuguese pharmaceutical company, conducted the initial research and development of eslicarbazepine acetate but later licensed it to Sunovion for further development and commercialisation in the US and Canadian markets.

"Aptiom is an important new treatment option with a well-established safety profile for healthcare providers and people living with epilepsy."

In February 2009, Bial granted the rights to Eisai Europe, a European subsidiary of Eisai, to market eslicarbazepine acetate under the trade name Zebinix in Europe.

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In April 2009, Zebinix obtained European approval as adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalisation and is now marketed in Europe.

Epilepsy Foundation chair of professional advisory board Joseph Sirven said patients with partial-onset epilepsy often require adjunctive treatment to achieve better seizure control.

"Aptiom is an important new treatment option with a well-established safety profile for healthcare providers and people living with epilepsy," Sirven said.

The company said Aptiom has significantly reduced the frequency of epileptic seizures compared with a placebo in three Phase III randomised, double-blind, placebo-controlled, safety and efficacy trials in which over 1,400 participants with partial epilepsy were enrolled.

FDA’s Division of Neurology Products acting director Eric Bastings said some patients with epilepsy do not achieve satisfactory seizure control from existing treatments.

"It is important we continue to make new treatment options available to patients," Bastings said.

The company expects to launch Aptiom in the US pharmacies in the second quarter of 2014.

Eslicarbazepine acetate is also under development for the treatment of partial-onset seizures with or without secondary generalisation, epilepsy, postherpetic neuralgia, diabetic neuropathic pain, neuropathic pain and for childhood epilepsy.

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