Posted from: Monday, June 04, 2018 - 10:48 AM - Present

Briviact Receives New Pediatric Indication

May 14, 2018 – The U.S. FDA has approved a new indication for Briviact® (brivaracetam) CV oral formulations, manufactured by UBC, Inc. Briviact oral forms are now indicated as a monotherapy and adjunctive therapy to treat patients at least four years of age who experience partial onset seizures.

In clinical trials, the safety and tolerability of Briviact oral formulations were found to be similar in pediatric patients as in adults. Only the oral formulations of Briviact were assessed. Its intravenous formulation has not been approved for patients younger than 16, as safety has not been established.

Epilepsy affects an estimated 470,000 children in the United States, making it one of the most common serious pediatric neurological disorders in the country. Approximately 10% to 20% of children with the disorder have inadequate seizure control with most available anti-epileptic drugs. Unlike some anti-epileptic treatments, Briviact does not require gradual dose increases over time. This allows prescribers to begin patients on a therapeutically effective dose on the first day without having to titrate slowly up from an initial dose.

First approved in 2016, Briviact is also approved as an adjunctive therapy to treat patients at least 16 years of age who have epilepsy and experience partial onset seizures.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Friday, June 22, 2018 - 11:52 PM.