viernes, 28 de septiembre de 2018

FDA approves new drug for the preventive treatment of migraine in adults- Drug Information Update



The US Food and Drug Administration (FDA) approved Emgality (galcanezumab-gnlm) for the preventative treatment of migraine in adults. This is the third FDA-approved biologic that acts by reducing the effect of CGRP, a molecule believed to play a role in migraine.  Aimovig (erenumab-aooe) was approved on May 17, 2018 and Ajovy (fremanezumab-vfrm) was approved on September 14, 2018.

A migraine is described as severe throbbing pain or a pulsing sensation, usually on just one side of the head. It's often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. Migraine attacks can cause significant pain for hours to days and can be so severe that the pain is disabling. Warning symptoms known as aura may occur before or with the headache. These can include flashes of light, blind spots, or tingling on one side of the face or in the arm or leg.

EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. Hypersensitivity reactions (e.g., rash, urticaria (hives), and dyspnea (shortness of breath)) have been reported with Emgality in clinical studies. The most common adverse reactions in Emgality clinical studies were injection site reactions, sinusitis, and urinary tract infection. 

For more information, please visit: Emgality (galcanezumab-gnlm)

No hay comentarios:

Publicar un comentario