Allergan announces FDA acceptance of new drug application for ubrogepant for the acute treatment of migraine

Allergan

11 March 2019 - Ubrogepant seeks to be the first oral calcitonin gene-related peptide receptor antagonist for the acute treatment of migraine.

Allergan today announced that the U.S. FDA has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults.

The NDA filing is based on the successful completion of four clinical trials – two pivotal studies, ACHIEVE I and ACHIEVE II, which demonstrated the efficacy, safety and tolerability of ubrogepant, as well as two additional safety studies. A 10 month review period has been assigned with the Prescription Drug User Fee Act in the fourth quarter of 2019.

Read Allergan press release


Michael Wonder

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Michael Wonder

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