Clinigen anti-epileptic drug approved in South Africa

AIM-listed pharmaceutical Clinigen’s adult anti-epileptic drug has been approved in South Africa.

Clinigen, which collaborated with health care firm Eisai, announced that Perampanel has gained regulatory approval for the treatment of partial-onset seizures, with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.

The company claimed that Perampanel is the only licensed anti-epileptic drug to selectively and non-competitively target alpha-amino (AMPA) receptors, which play a role in the onset of seizures.

Epilepsy affects one in every 100 people in South Africa, which amounts to about half a million people, according to the National Office of Epilepsy South Africa, while 20-40% of people with newly-diagnosed epilepsy can become refractory to currently available treatments, which require further adjunctive medication, according to Epilepsia, a peer-reviewed medical journal.

The drug's approval was based on three phase three studies and an open extension study.

"Perampanel is the second product we are working on together with Eisai in South Africa. We have forged a strong partnership, based on Eisai's innovative products and our ability to leverage our extensive distribution network in the region and local expertise. Together, we can enable access to perampanel where it is needed most," said Johann Willemse, chief commercial officer for the rest of world at Clinigen.

Neil West, vice president global neurology business group at Eisai, added: "Ensuring patient access to new treatments underlines Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide."

Shares in Clinigen were up 1.07% to 850p at 1256 GMT.