Please login to the form below

Not currently logged in
Email:
Password:

Eisai gains monotherapy licence for epilepsy drug Zonegran

Once-daily pill will compete with Novartis' Tegretol

The European Medicines Agency (EMA) has issued Eisai's once-daily oral epilepsy drug with a monotherapy licence for the most common type of the condition.

It expands Zonegran's European indications and means the drug can now be used to treat partial seizures (with or without secondary generalisation) in adultswith newly diagnosed epilepsy on its own.

Dr Bettina Bauer, head of EMEA Epilepsy Business Unit at Eisai Europe, said: "Zonegran is already a successful once-daily, add-on therapy for patients with epilepsy. The new monotherapy indication means this important treatment can now be used in newly diagnosed patients to help improve seizure control.”

“We will be working closely with health authorities and clinicians across Europe to ensure patients have access to this treatment from first diagnosis,” she added.

It is a significant step up for Zonegran, which was first approved in Europe in 2010 as an adjunctive treatment forpartial seizures, because monotherapy is the preferred option for managing epilepsy as it reduces the potential for adverse drug interactions.

The new approval means it will compete directly with Novartis' Tegretol (carbamazepine), compared to which Zonegran's once-daily dosing may be an advantage. Tegretol should be given in a number of divided doses during the day, although initially once or twice-daily dosing is recommended.

Zonegran's approval was based on a phase III trial comparing once-daily Zonegran with twice-daily controlled release Tegretol that involved 583 adults with newly-diagnosed partial-onset epilepsy.

The study's primary endpoint was the proportion of seizure-free patients at six months and it showed Zonegran was effective and well tolerated and met the study's criteria of non-inferiority.

Zonegran is a second-generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure that is unrelated to any other AEDs.

There are an estimated six million people living with epilepsy in Europe and an estimated 50 million people worldwide.

The global epilepsy market is estimated to be worth $4bn and Eisai, whose otherepilepsy drugs include the CHMP-recommended perampenal, Zebinix and Inovelon, has ambitions to become a top-three player in the therapy area.

5th July 2012

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Lucid Group Communications Limited

We are industry-leading thinkers when it comes to education. We use the latest academic thinking on the psychology of behaviour...

Latest intelligence

The Heart of the Matter 9: Context is King
McCann Complete Medical outlines why multichannel communications - anchored in strong clinical data from journal publications - must not only be transparent, they must also provide a clear clinical context...
Cell and gene therapies: on course for commercial success?
...
eyeforpharma_h_logo.png
Make Anthill your strategic partner in Barcelona
We are excited to attend and exhibit at eyeforpharma Barcelona 2017 (March 14-16th), and present two multichannel strategy workshops....

Infographics