Teva's AJOVY Joins Migraine Prevention Meds on the Market
A PPM Brief
Teva Pharmaceuticals USA (North Wales, PA) has earned FDA approval of the second fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP) for the prevention of migraine in adults. Aimovig (erenumab-aooe), administered once monthly, was first in this class, approved in May 2018.
The biologic fremanezumab-vfrm, now branded as Ajovy, showed efficacy and safety in its Phase III HALO trials, in which subjects (n = 1,036) receiving the monthly medication experienced 4.6 fewer headache days per month, on average, compared to 2.5 days with placebo. Patients receiving a quarterly dosage experienced 4.3 fewer headache days per month, on average, compared to 2.5 days with placebo.
In Phase III episodic migraine trials (n = 875), Ajovy treatment significantly reduced monthly migraine days to 4.9 days for monthly (P < 0.001) and 5.3 days for quarterly (P < 0.001) dosing compared with 6.5 days for placebo. More on the data from Teva and its CGRP competitors.
The subcutaneous injection may be administered monthly (225 mg/1.5 mL) or quarterly (675 mg) to the abdomen, thigh, or upper arm. The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.
“With limited availability of preventive treatment options, AJOVY provides physicians with an important new option for their patients,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D at Teva, in a news release. “This approval furthers our ongoing commitment and experience in neurological conditions like migraine.”
The medication was originally trialed for the treatment of cluster headache as well, but studies were stopped when it seemed the 12-week treatment endpoint for this indication was unlikely to. be met. (Read the back story).
Here, PPM editorial advisor and headache specialist Larry Robbins, MD, provides insight into the CGRP class as well as questions still being considered for prescribing and usage.
