Second MAb migraine drug gains FDA approval

15 September 2018

The US Food and Drug Administration has approved Ajovy (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults, making it the second anti- calcitonin gene-related peptide (CGRP) treatment for migraine to be cleared for marketing.

Teva Pharmaceutical Industries’ (NYSE: TEVA) Ajovy, a humanized monoclonal antibody that binds to CGRP ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675mg) and monthly (22mg) dosing options, the company noted.

The approval is a significant boost for the Israeli drugmaker, which is facing strong competition for its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate) and has been battered by falling sales of its generic medicines in the USA. Teva’s shares gained 5.95% to $24.21 in after-hours trading in New York on Friday,

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