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Playing catch-up, Eli Lilly is hustling positive PhIII CGRP migraine data to the FDA as late-stage rivalry heats up

Eli Lilly is hustling up a biologics application for its closely-watched migraine drug galcanezumab after posting some remarkably consistent and positive late-stage data from three Phase III studies.

The top-line data from the Lilly $LLY study demonstrated that the 120 and 240 mg doses reduced the average number of migraine days by 4.3 to 4.8 days and 4.2 to 4.6 days a month. The placebo arm had a 2.3 to 2.8 day monthly drop in migraine days, on average, leaving the drug with a consistent two-day advantage that will likely do fairly well in the marketing battle to come as Teva, Alder and the powerhouse duo of Novartis $NVS and Amgen $AMGN hustle their competing CGRP drugs to the market.

Novartis and Amgen — 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. Then their STRIVE study delivered an average reduction of 3.2 and 3.7 days from baseline in monthly migraine days for the 70 mg and 140 mg doses, respectively, as compared to a 1.8-day reduction in the placebo arm. The data so far have all indicated that these drugs can consistently reduce migraine days by one or two days, as analysts try to make comparisons with different patient populations and a variety of baseline scores to start with.

Despite the number of CGRP drugs angling for the lead here, Biohaven $BHVN recently in-licensed a similar drug from Bristol-Myers Squibb and scored a very successful IPO with it just a few days ago.

“The robust results from these three studies bring us one step closer to helping people experience more migraine-free days, an important treatment goal for those living with this serious disease,” said Christi Shaw, president of Lilly Bio-Medicines. “The impact of migraine is underestimated, with people who experience migraine attacks often missing work, family activities or social engagements. For patients with as few as one migraine headache day per week, this can mean more than 50 days of lost productivity a year.”


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