UCB now has approval for its new epilepsy drug Briviact on both sides of the Atlantic after a green light from the US FDA.
The US regulator has given the go-ahead to Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients aged 16 years and older with epilepsy. There are around 2.9m people in the US with active epilepsy, according to the FDA.
Briviact's effectiveness was studied in three clinical trials involving 1,550 participants, which showed that the drug was effective in reducing the frequency of seizures when taken along with other medications.
The US approval comes just a few weeks after Briviact was given the nod in Europe and in the meantime UCB has launched the product in Germany and the UK in tablet, oral solution and injectable formulations.
Billy Dunn, director of the FDA's division of neurology products, said Briviact provides a welcome new treatment option for epilepsy patients. "Patients can have different responses to the various seizure medicines that are available", he said in a statement.
Unlike many current epilepsy drugs, brivaracetam does not require dose titration so patients can get a full therapeutic dose to help control seizures from the start of treatment. The drug binds to synaptic vesicle protein 2A, which is also targeted by levetiracetam so is a well-established treatment target in epilepsy.
UCB has said it plans to launch Briviact after the US Drug Enforcement Administration (DEA) rules on scheduling for the drug, a process which gives an indicator of its potential for misuse and the level of control required for prescribing. The company said it expects this to occur within 90 days, but has not yet indicated its pricing plans for the product.
The recommended starting dose of Briviact is 50mg or 100mg a day, with a maintenance dose of 50mg to 200mg. A 56-count supply of 50mg tablets costs around £130 at UK list prices, according to MIMS data.
Belgium-headquartered UCB is already an established player in epilepsy with drugs such as Vimpat (lacosamide) and Keppra (levetiracetam), which is off-patent in most major markets.
Briviact is positioned as a successor to Keppra, which despite generic competition remains a big product for UCB with sales of €565m in the first nine months of 2015, to which Vimpat added another €495m. The company is due to report its fourth quarter results on Friday.
Brivaracetam is one of three new drugs coming out of UCB's pipeline that are expected to drive growth in the coming years, along with romosozumab for osteoporosis and lupus treatment epratuzumab.