Phase 3 success keeps Teva in migraine race
- Israeli company Teva Pharmaceutical has announced its migraine prevention candidate fremanezumab has met all its primary and secondary endpoints for two dosing regimens in patients with chronic migraine.
- Participants in the HALO study treated with the monoclonal antibody, which works by targeting a protein known as CGRP, had 2.5 fewer days per month of headaches of at least moderate severity over the 12 weeks after the first dose compared with placebo, both in monthly and quarterly dosing. There were also significant improvements compared with placebo in all secondary endpoints for those regimens, including response rate, onset of efficacy, efficacy as monotherapy, and disability.
- Additional data on patients with frequent episodic migraine is expected in the coming weeks, and Teva plans to submit a biologics license application (BLA) for fremanezumab later in 2017.
The launch of triptans improved quality of life for many migraine sufferers, yet the drugs aren't a magic bullet for all patients. In search of the next great migraine medication, drugmakers have increasingly honed in on CGRP-targeting treatments. Teva now finds itself racing against competitors to make sure its product makes it to market first.
"These top-line results reflect our differentiated clinical development program and add to a growing body of evidence that supports the development of CGRP targeted therapy in migraine, including patients with very severe forms of the disease, with flexible dosing regimens," Teva's Chief Medical Officer Marcelo Bigal said in a May 31 statement.
Other companies fighting for prominence in the space include Amgen and Novartis, which have reworked their 2015 collaboration for erenumab, changing the deal terms and royalties, and are pushing towards an approval filing in the second quarter of 2017.
Novartis and Amgen have tested 70 mg and 140 mg doses erenumab in the clinic, with both sporting significant reduction in the number of days patients reported having a migraine.
An approval would put them in the lead, but others aren't far behind. Eli Lilly, for instance, announced in mid-May its candidate galcanezumab met the primary endpoints of three Phase 3 studies, putting the company on track for a BLA submission in the second half of 2017. And Alder BioPharmaceuticals is also moving a drug through development.
For headache drug developers, dosing will be a key way to differentiate their products. Teva's candidate benefits from showing efficacy on monthly and quarterly schedules. Novartis and Amgen's drug, along with Lilly's galcanezumab, are designed for once monthly dosing. If doctors and payers view the CGRP-targeting drugs as relatively similar, a less frequent dosing could be a more convenient option for patients.
Alders' epitinezumab, which is a little further behind, also is aiming for once-quarterly dosing but is administered intravenously rather than the less invasive subcutaneous injections used for the other drugs.
Regardless of the order in which the various CGRP-focused migraine drugs enter the market, there remains plenty of opportunity for return on investment. Migraine patients total in the millions, an enormous patient population that hasn't gone unnoticed by drugmakers. Otsuka, for example, snagged Japanese rights to fremanezumab last month in return for a $50 million payment up front and milestone and royalty payments down the line.
- Teva Pharmaceutical Press release
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