US FDA eases Teva headache with Ajovy approval
Earlier this week, the US Food and Drug Administration (FDA) approved Teva Pharmaceuticals’ Ajovy (fremanezumab-vfrm) injection – the first calcitonin gene-related peptide (CGRP) treatment with quarterly and monthly dosing options. Ajovy is indicated for the preventive treatment of migraine in adults.
The monoclonal antibody works by binding to the CGRP ligand and blocking its binding to the receptor, which has been linked to pain signals in migraines.
Novartis is the only other firm to have experienced regulatory success in the CGRP space, which just weeks earlier received European approval for migraine treatment Aimovig (erenumab), and US approval in May 2018. Allergan, Amgen and Eli Lilly are all also working on their own CGRP treatments.
According to Teva, Ajovy will be made available to patients in approximately two weeks, with a price tag of $575 (€491) per monthly dose, and $1,725 per quarterly dose.
“Our entire organisation is proud to bring this new biologic product forward at a responsible price, and we are eager to work with insurers to encourage coverage that provides full access and availability in this much needed category,” said Teva’s executive vice president and head of North America commercial, Brendan O’Grady, in a statement.
Manufacturing concerns alleviated
Ajovy’s path to regulatory success attracted much interest as the contract manufacturing organisation (CMO) responsible for making Ajovy’s active pharmaceutical ingredient (API) received both an FDA warning letter and Form 483 this year. The regulatory concerns relate to CMO Celltrion’s Incheon biomanufacturing facility, based in South Korea.
At the time, Teva CEO Kåre Schultz confirmed that although made at the same facility, API manufacturing was not of regulatory concern for the Agency.
“It’s a huge facility, but the part of the facility that was inspected was the finish-fill and pack manufacturing side, not the API part,” said Schultz in an investor call earlier in February 2018.
“But from a regulatory point of view, it’s the same facility site number, so to speak,” he added.
The issues delayed the final decision by just three months, with US approval previously expected by mid-June.
Ajovy’s regulatory approval will be a welcome reprieve for Teva, which announced, and has since begun to implement, plans to reduce its workforce by 14,000 and to restructure its network of facilities as part of a global $3bn cost-saving plan.
Teva did not respond to a request for comment ahead of publication.