Allergan to file ubrogepant for migraine early next year
Allergan is gearing up to file its oral CGRP receptor ubrogepant in the US for the treatment of migraine, following the success and completion of two safety studies.
The Dublin, Ireland-headquartered group said it plans to submit a marketing application for the drug in the first quarter of next year, and a believes it will be the first oral CGRP receptor antagonist submitted in the US for the acute treatment of migraine with or without aura.
The announcement rides on the back of findings from a one-year study that Allergan noted “continue to support positive safety and tolerability profile for ubrogepant”, and also a two-month hepatic safety study in healthy volunteers which demonstrated no signal of drug-induced liver injury.
This follows positive efficacy data released at the beginning of this year.
Read more: http://www.pharmatimes.com/news/allergan_to_file_ubrogepant_for_migraine_early_next_year_1256094
The Dublin, Ireland-headquartered group said it plans to submit a marketing application for the drug in the first quarter of next year, and a believes it will be the first oral CGRP receptor antagonist submitted in the US for the acute treatment of migraine with or without aura.
The announcement rides on the back of findings from a one-year study that Allergan noted “continue to support positive safety and tolerability profile for ubrogepant”, and also a two-month hepatic safety study in healthy volunteers which demonstrated no signal of drug-induced liver injury.
This follows positive efficacy data released at the beginning of this year.
Read more: http://www.pharmatimes.com/news/allergan_to_file_ubrogepant_for_migraine_early_next_year_1256094