Two Epilepsy Treatments Get Supplemental Approval

SEPTEMBER 15, 2017
Kevin Kunzmann
Two antiepileptic drugs were approved for supplemental use in the US this week.

BRIVIACT (brivaracetam), an antiepileptic drug from UCB, has received supplemental new drug application (sNDA) approval from the US Food and Drug Administration (FDA).

The FDA approved the drug as a monotherapy for partial-onset (focal) seizures (POS) in epilepsy patients aged 16 years or older. BRIVIACT was previously approved by the FDA as an adjunctive POS treatment for this same patient age group.

The monotherapy indication builds on what Dr. Pavel Klein, director of the Mid-Atlantic Epilepsy and Sleep Center, said is an “already strong and compelling clinical profile for BRIVIACT.”

“In helping to progress their journey towards seizure freedom by providing a choice of treatment which can be initiated as monotherapy, at a therapeutic dose, from day one, BRIVIACT provides an additional treatment choice for neurologists and their patients,” Klein said.

Prior to the UCV supplemental application for monotherapy indication, the company had received a recent General Advice Letter from the FDA, which explained the ability to extrapolate the efficacy and safety of approved adjunctive therapy drugs for the treatment of POS, to their use as monotherapy treatment.

Due to the FDA’s allowed assessment of extrapolated data, UCB was able to support its BRIVIACT sNDA with clinical trial data involving more than 2,400 adult POS patients.

“We are delighted that, with this new monotherapy indication for BRIVIACT, we can support people with epilepsy to reach their treatment goals,” Jeff Wren, Executive Vice President, Head of UCB's Neurology Patient Value Unit, said. “Coming just 18 months after our launch in the US, 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.”

The FDA also approved the sNDA of eslicarbazepine acetate (Aptiom), a once-daily, immediate release antiepileptic drug.

The sNDA expands Aptiom’s indication to include treatment of POS children from ages 4 to 17 years old.

The approval was based on the FDA permitted extrapolation of data to support Aptiom’s pediatric safety and efficacy as both a monotherapy and adjunctive therapy.

Steven Wolf, MD, Director of Pediatric Epilepsy and Associate Professor of Neurology at Mount Sinai Health System, said there continues to be a “critical need for new therapeutic options” for POS, especially in children and adolescent patients.

“The unpredictable nature of seizures can be disruptive in the lives of these young people and their families, friends and community,” Wolf said. “It is important that physicians have additional treatment options that address patient needs.”

A press release regarding the BRIVIACT decision was made available.

A press release regarding the Aptiom decision was made available.

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