April 25, 2024

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AbbVie: EMA’s CHMP To Review Marketing Authorization Application For Migraine Drug Atogepant

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(RTTNews) – AbbVie (ABBV) declared it has submitted a promoting authorization software or MAA to the European Medicines Company for atogepant for the prophylaxis of migraine in grownup patients who have at least 4 migraine times per month.

The Committee for Medicinal Solutions for Human Use or CHMP will review the atogepant MAA, and will problem an viewpoint that will be valid for all member states of the European Union, as perfectly as Iceland, Lichtenstein, Northern Ireland and Norway.

The submission is dependent on two pivotal Section 3 Progress and Development reports analyzing the safety, efficacy, and tolerability of atogepant in adult sufferers with episodic and continual migraine.

Migraine is a complex neurological illness, and is highly widespread, impacting additional than 1 billion folks worldwide.

If authorized, atogepant would be the initial each day oral calcitonin gene-relevant peptide or CGRP receptor antagonist for the prophylaxis of migraine for adult sufferers in Europe. And, AbbVie would come to be the only company with a portfolio of medicines to offer two treatment plans for persistent migraine, one oral and a person injectable

In both of those, the Phase 3 Progress and Phase 3 Progress scientific tests, all doses have been well tolerated, and the all round protection profiles had been reliable with security results noticed in prior experiments for the prophylaxis of episodic migraine and continual migraine populations. The most common adverse situations ended up constipation and nausea.

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