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UCB’s antiepileptic drug gains new US indication

FDA approves Briviact as a monotherapy to treat POS

UCB

The US Food and Drug Administration (FDA) has approved UCB’s Briviact (brivaracetam) CV as a monotherapy treatment option for epilepsy patients aged 16 years and older with partial-onset focal seizures (POS).

As a result, patients who are eligible for the group’s antiepileptic therapy can now be started on the drug with no gradual dose escalation required.

Jeff Wren, executive vice president and head of UCB’s neurology patient value unit, said: “We are delighted that, with this new monotherapy indication for Briviact, we can support people with epilepsy to reach their treatment goals.”

The new indication comes 18 months after the drug’s initial launch in the US, where it was originally approved as an adjunctive therapy for POS patients in the same age group.

Wren added: “This is evidence of our commitment to increasing the speed at which our therapies are approved and made available to as many patients as possible.

“With this new indication, we build on our longstanding commitment to help people with seizure disorders at every point in their journey.”

Epilepsy is currently the fourth most common neurological condition worldwide and affects approximately 65 million people, according to UCB.

Wren concluded: “Discovering, validating and improving access to new and innovative solutions to support people living with epilepsy has been, and will continue to be, a core UCB mission.”

Briviact is already approved in the EU as adjunctive therapy for POS, however UCB said that the EMA has ‘different’ regulatory requirements for approval of monotherapy indications, and the group did not reveal whether it was filing for a new indication in the EU.

Article by
Gemma Jones

20th September 2017

From: Regulatory

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