UCB gets FDA nod for Nayzilam
UCB has received the Food and Drug Administration’s blessing for Nayzilam (midazolam) nasal spray CIV, a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older.
Nayzilam is the first and only FDA-approved nasal option for treating seizure clusters, and the first new medication approved to treat seizure clusters in more than 20 years in the U.S., the company said.
"As global leaders in epilepsy, the approval of Nayzilam complements our already strong epilepsy portfolio, improving our ability to provide value to people living with poorly controlled seizures, and builds on our passion and expertise in this field. We are pleased to expand and diversify the solutions we can offer to the epilepsy community, providing an innovative and differentiated solution to help support management of seizure clusters," UCB CEO Jean-Christophe Tellier, said.
"When a patient experiences seizure clusters, there is often significant impact on their overall quality of life, in addition to posing greater risks for increased emergency department related hospitalizations and more serious seizure emergencies," said Steven Chung, executive director and program chair of the Neuroscience Institute and director of the Epilepsy Program at Banner – University Medical Center, said.
Nayzilam is the first and only FDA-approved nasal option for treating seizure clusters, and the first new medication approved to treat seizure clusters in more than 20 years in the U.S., the company said.
"As global leaders in epilepsy, the approval of Nayzilam complements our already strong epilepsy portfolio, improving our ability to provide value to people living with poorly controlled seizures, and builds on our passion and expertise in this field. We are pleased to expand and diversify the solutions we can offer to the epilepsy community, providing an innovative and differentiated solution to help support management of seizure clusters," UCB CEO Jean-Christophe Tellier, said.
"When a patient experiences seizure clusters, there is often significant impact on their overall quality of life, in addition to posing greater risks for increased emergency department related hospitalizations and more serious seizure emergencies," said Steven Chung, executive director and program chair of the Neuroscience Institute and director of the Epilepsy Program at Banner – University Medical Center, said.