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U.S. FDA approves AbbVie’s migraine prevention drug By Reuters


© Reuters. FILEPHOTO: This illustration, taken on May 21st 2021 shows test tubes positioned in front of an Abbvie logo. REUTERS/Dado Ruvic/Illustration


(Reuters) -AbbVie Inc said on Tuesday the U.S. health regulator approved its once-daily oral medicine for preventive treatment of migraine in adults, adding a third drug to the drugmaker’s arsenal of therapies for severe headaches.

The drug, Qulipta, which AbbVie (NYSE:) will launch in early October, will enter a crowded market for migraine prevention drugs such as Eli Lilly (NYSE:)’s Emgality, Amgen Inc (NASDAQ:)’s Aimovig and Biohaven Pharmaceutical Holding Co (NYSE:) Ltd’s Nurtec ODT.

Based on Refinitiv data, analysts believe the drug would bring in over $640m by 2025.

Qulipta, along with Botox (an anti-wrinkle and chronic headache treatment) and Ubrelvy (an acute migraine medication), was purchased by AbbVie as part of the Allergan $63 billion acquisition.

Qulipta falls under the calcitonin gene related peptide (CGRP), receptor antagonists. Also known as “gepants”, Qulipta acts by blocking a pathway which appears to play a part in migraine activation.

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Data from a late stage study supporting Qulipta’s approval by the Food and Drug Administration shows that it caused an statistically significant decrease in monthly headache days for patients when compared with placebo.

AbbVie reported that approximately 39 million people suffer from migraine, which is characterized by severe headaches and symptoms like light sensitivity or nausea.

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