FDA Grants Priority Review to Fremanezumab for Migraine Prevention

Marcelo Bigal, MD, PhD, Chief Scientific Officer and Head of Specialty R and D at Teva

Marcelo Bigal, MD, PhD

The FDA has granted a priority review designation to fremanezumab for the prevention of migraines, according to Teva Pharmaceuticals, the company developing the anti-CGRP inhibitor. Under the Prescription Drug User Fee Act, the FDA is likely to decide on the application by September 2018.

The application for fremanezumab was based on findings from the phase III HALO study. In the trial, for chronic migraine, fremanezumab showed a significant reduction in monthly headache days for both monthly dosing (-4.6 days) and quarterly dosing (-4.3 days), when compared against placebo (-2.5 days; P <.0001) during the 12-week period after the first dose.

In the episodic portion of the HALO study, monthly migraine days during the 12-week period after the first dose of fremanezumab were reduced by -3.7 days (monthly regimen, baseline 9.2 days) and -3.4 days (quarterly regimen, baseline 9.1 days), compared with a -2.2—day reduction with placebo (baseline 9.1 days).

“The progression of these clinical programs for fremanezumab underscores the potential to advance the treatment paradigm for a large portion of the migraine and headache patient community in need,” Marcelo Bigal, MD, PhD, Chief Scientific Officer and Head of Specialty R&D at Teva, said in a statement. “We look forward to the potential to make fremanezumab commercially available for the prevention of migraine for patients in the United States next year.”

The HALO trial examined fremanezumab for episodic migraine (EM) and chronic migraine (CM) at 2-dose regimens — quarterly and monthly. The EM arm had 875 patients assigned either placebo (n = 294) or quarterly (n = 291) or monthly fremanezumab (n = 290), while the CM arm had 1130 patients randomized to either monthly or quarterly fremanezumab or placebo (376 patients each).

In the CM arm, similar results were seen in the reduction of weekly headache days for week 1 (-1.1 days; P <.0001) against placebo (-0.5 days), and in the number of monthly days of acute headache medication use in both monthly (-4.2 days) and quarterly (-3.7 days) versus placebo (-1.9 days; P <.0001).

The chronic migraine study saw improvements in overall health status, as measured by the EuroQol 5-dimensions 5-response level questionnaire, as well as in overall work productivity loss, as measured by a composite of absenteeism and impairment while working.

Both the episodic (monthly 47.7%, quarterly 44.4%, placebo 27.9%; P <.0001) and chronic (monthly 40.8%, quarterly 37.6%, placebo 18.1%; P <.0001) migraine groups saw a ≥50% reduction in monthly average number of migraine days of least moderate severity for both dosing regimens.

“If you have chronic migraine, you want to bring them down to episodic, and once they are episodic, the goal is to get you to a lower frequency and prevent them from becoming chronic again,” Bigal, said when the findings were presented. “The results, by default, need to be seen together. Having the full gamut [to treat both CM and EM] is what is important about this treatment.”

In addition to the FDA submission, Teva also announced that the FDA had granted a fast track designation to fremanezumab for cluster headache. The treatment is being explored in the phase III ENFORCE trial for this indication. The trial is expected to conclude in 2019. A separate phase II study is also looking at fremanezumab for post-traumatic headache disorder.