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Teva Wins FDA Nod for Migraine Drug, Sets Price in Line with Amgen’s

Xconomy National — 

A Teva Pharmaceutical migraine-prevention drug has won FDA approval, the second therapy in this new drug class to receive the regulatory nod this year.

The Friday approval for the Teva (NYSE: TEVA) drug fremanezumab (Ajovy) came a little earlier than expected; the target date for the FDA decision was Sept. 16. The drug is part of class of drugs called calcitonin gene-related peptides (CGRP). These antibody drugs work by blocking the CGRP protein, which is associated with migraine pain. The Amgen (NASDAQ: AMGN) CGRP drug erenumab (Aimovig) was approved in May.

Amgen’s migraine drug is a once-monthly injection. Teva, which is headquartered in Israel, can now offer migraine patients the option of receiving treatment once a month or once every three months. The FDA approved a 225 mg dose that is administered monthly, and a 675 mg dose given quarterly as three injections. Teva said the wholesale cost of its drug will be $575 for the monthly dose—the same price as Amgen’s drug. For quarterly dosing, Teva’s drug will cost $1,725. Teva said that it expects its drug, supplied in pre-filled syringes, will be available in pharmacies in two weeks.

CGRP drugs don’t prevent migraine headaches entirely, but they have been shown in clinical trials to reduce the frequency. FDA approval of the Teva drug was based on data from Phase 3 studies that enrolled 1,130 patients. In those studies, the reduction in the number of days that patients experienced migraine headaches was statistically significant, Teva said. The most common side effect reported was reactions at the injection site. Teva’s attempt to broaden the potential applications of its drug have fallen short, however. A separate Phase 3 trial testing the drug as a treatment for cluster headaches failed.

The Teva migraine drug was initially expected to face an FDA decision in June, but problems at a third-party manufacturer led to a delay. Two other companies are still chasing Amgen and Teva with their respective CGRP migraine drugs. Indianapolis-based Eli Lilly (NYSE: LLY) expects an FDA decision for its drug, galcanezumab, by the end of September. Alder BioPharmaceuticals (NASDAQ: ALDR), based in Bothell, WA, plans to file for FDA approval of its drug, eptinezumab, in early 2019.

The fremanezumab approval is a key win for Teva. Late last year, the company implemented a corporate restructuring to address its flagging financial performance. In a research note, Evercore ISI analyst Umer Raffat wrote that winning the FDA nod helps Teva’s management restore credibility with its investors. He added that monthly and quarterly dosing, as well as pricing on par with Amgen’s migraine drug, makes the Teva drug competititive.

Here’s more on the development of Teva’s fremanezumab and other therapies in this new class of migraine-prevention drugs.

Photo by Flickr user r.nial bradshaw via a Creative Commons license