With a second big clinical failure, Teva Pharmaceutical is abandoning efforts to extend the use of its approved migraine drug to the treatment of cluster headaches, a rarer form of headache that typically affects one side of the head around the eye or the temple.
Teva (NYSE: TEVA) said Tuesday that an interim analysis of a Phase 3 study found that its drug fremanezumab (Ajovy) was unlikely to reduce the average number of headache attacks over a four-week treatment period, the main goal of the study. As a result, the Israel-based company, which has US headquarters in Parsippany, NJ, said it would end the program.
The drug’s first failure in cluster headache happened last June. At that time, Teva announced it would stop testing fremanezumab as a treatment for chronic cluster headaches, which last for weeks or months and do not have a remission period of longer than one month. The failure announced today was for episodic cluster headache—one to four short headaches per day lasting 15 to 20 minutes.
Teva said that it will continue to explore other applications for fremanezumab. A program in post-traumatic headache is currently in Phase 2 testing.
Fremanezumab is part of a new class of antibody drugs developed to block a protein associated with pain called calcitonin gene-related peptide (CGRP). Last September, the FDA approved fremanezumab for migraines in both monthly and once-every-three months dosing. The company launched the drug soon after; it generated approximately $3 million in sales the rest of the year. That figure may underrepresent patient uptake of the drug. Teva offered a temporary program last year that provided the drug for free as long as patients provided a physician’s letter stating the treatment was medically necessary. Developers of other CGRP drugs offered similar programs.
Amgen (NASDAQ: AMGN was the first to the market with its CGRP drug for migraines last May; Eli Lilly (NYSE: LLY) won the FDA nod for its medicine in October. Alder BioPharmaceuticals (NASDAQ: ALDR) announced Monday that the FDA will review its CGRP drug, eptinezumab. If approved, the Bothell, WA, company plans to launch the drug in the first quarter of 2020. While that would be more than one year after the other CGRP drugs reached the market, Alder says its drug has the advantage of a quicker onset of therapeutic effect and quarterly dosing, compared to the monthly doses offered by its rivals.