Teva has brought in its second successful Phase III study of its CGRP migraine drug fremanezumab (TEV-48125), racking up a fresh slate of promising data across all endpoints that will soon be packaged and delivered into the hands of regulators.
Teva recruited a heavily afflicted group of patients for this episodic study with a mean number of 9.1 migraine days per month going in. Their $TEVA core data boils down to this: a 1.5-day advantage in reduced migraine days for the drug arm, putting it in the mix of around 2 days improvement across a full slate of CGRP rivals tested in a wide variety of mid- and late-stage studies.
Umer Raffat at EvercoreISI has been following the numbers, and highlighted this point:
(I)n today’s data, there is another impt tidbit: Teva prospectively randomized a subgroup of patients in this episodic trial on stable prophy meds … and in this subgroup, Teva showed a 1.7-2 day stat sig migraine day reduction (both for quarterly and monthly doses). This may also help from labeling perspective.
Raffat declined to compare these new numbers for episodic migraine with Amgen or Lilly, noting the difference in trial length that makes it impossible to line up the stats.
Fremanezumab given monthly improved the average number of migraine days, relative to baseline, by 41.6% for the duration of the trial (-3.7 days vs. -2.2 days for placebo, p < 0.0001). Number of days with disability were decreased by 64.7% (p =0.0021) and medication consumption was decreased by 39.0%( p < 0.0001). The quarterly SC dose, which was uniquely tested in this program, also yielded highly significant results for decrease in migraine days (-3.4 days or 37.0%, p < 0.0001) and for all other comparisons. Also unique to this development, both dose regimens highly significantly improved migraine in subjects on stable doses of other prophylactic medications (-4.0 days for monthly dose vs -2.0 days for placebo, p = 0.001; -3.7 days for quarterly dose, p = 0.006).
It all looks good enough for an approval, with decent odds that this drug will appear on the market alongside a slate of rivals next year. Teva, though, is hoping that its monthly and quarterly dosing regimens will help differentiate it from the competition to come.
“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. This is a major advance on existing data. The efficacy and rapid onset, as both add-on and monotherapy, quarterly dosing, and effect on disability and quality of life indicate that this therapy has the potential to set new and different benchmarks in the relief of migraine suffering,” said Teva R&D chief Michael Hayden in a statement. “We are immensely proud to be able to bring to the migraine community the hope that they might soon have a new option that could provide a meaningful reduction in the migraine burden patients habitually suffer.”
A few weeks ago it was Eli Lilly’s $LLY turn to celebrate its Phase III results for galcanezumab, with a consistent 2-day reduction in monthly migraines. Little Alder $ALDR is also planning to wage a commercial war with their drug. And Allergan $AGN has a late-stage program underway for an oral CGRP therapy it in-licensed from Merck in 2015 with a $250 million upfront. Novartis $NVS and Amgen $AMGN — credited as the frontrunners in the race to the first OK — were the first to come up with positive Phase III data for erenumab (AMG 334) last fall, when a 70 mg dose scored an average 1.1 day per month drop in migraine episodes.
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