More good news for Teva in migraine
- The second part of Teva Pharmaceutical's HALO study has come good for the company – quarterly and monthly doses of fremanezumab clinically and statistically improved all endpoints and 12 pre-specified analyses in the prophylaxis of episodic migraine arm of the trial.
- Monthly fremanezumab reduced the number of migraine days by 41.6% relative to baseline (-3.7 vs -2.2 days for placebo; p <0.0001); decreased the number of days with disability by 64.7% (p=0.0021); and medication consumption fell by 39.0% (p<0.0001). Quarterly fremanezumab reduced migraine days by a slightly smaller but still significant degree (37.0%; p<0.0001), and all other comparisons were also statistically significant.
- Teva plans to submit a Biologics License Application (BLA) to the Food and Drug Administration for both episodic and chronic migraine in 2017, hoping for approval and launch in the second half of 2018.
These results, following Teva's positive data in the prevention of chronic migraine in the other arm of the HALO study, are another piece in the jigsaw for the validation of the CGRP-targeting treatments, and their use in prophylaxis in the hard-to-treat indications of chronic and episodic migraine.
"Teva’s HALO trials are the only Phase III anti-CGRP studies to demonstrate efficacy with both monthly and quarterly dosing for chronic and episodic patients and in patients already receiving prevention therapies," bragged Michael Hayden, president of Global R&D and CSO at Teva.
Umer Raffat, analyst at Evercore ISI, sees the positive data for quarterly dosing as important from the competitive landscape perspective.
Most of the other drugs in development from competitors, including Novartis and Amgen, and Eli Lilly & Co., are only being tested for a monthly dose. Yet, small biotech Alder Pharmaceuticals is also testing a quarterly dose, albeit an intravenous one, not subcutaneous like Teva's drug.
Raffat also point out that the positive results in the patients who are on stable prophylactic medications may also help from a labeling perspective. While most of the drugs in the CGRP class have performed similarly in clinical trials, dosing could be a major differntiator for payers and could shift which company gains dominant market share.
In 2018, migraines are expected to affect 37 million people across the U.S., with 12 million of those with diagnosed migraine having headaches for four or more days a month. This has a huge impact on work, education, social activities and quality of life, and creates a large potential market for drugs that can prevent, rather than just treat, migraines.
- Teva Pharmaceutical Statement
Follow Suzanne Elvidge on Twitter