Results cont.• Migraine affects more than 1 billion people worldwide1 and is associated with substantial decline in

quality of life due to migraine-related disruptions in professional, academic, and social activities2• Rimegepant is an orally administered small molecule calcitonin gene-related peptide receptor

antagonist that has demonstrated efficacy and safety in the acute treatment of migraine in 3 separate Phase 3 clinical trials3-5 — 2 using an oral tablet and 1 with a novel orally disintegrating tablet (ODT) utilizing the Zydis® fast-dissolve technology; rimegepant ODT demonstrated statistically significant pain relief and return to normal function at 60 minutes and through 48 hours postdose

• The Migraine-Specific Quality of Life (MSQoL) Questionnaire (MSQ v.2.1) is a widely used, validated,6disease-specific 14-item tool that measures the extent to which migraine restricts and/or prevents subjects’ daily functioning across 3 domains:

– Role - Restrictive (RR): 7 items on limitation of daily social and work-related activities– Role - Preventative (RP): 4 items on prevention of activities– Emotional Function (EF): 3 items on the emotional impact of migraine

• The minimal clinically important differences in MSQoL scores are 5.0 for RR, 5.0 to 7.9 for RP, and 8.0 to 10.6 for EF7

• The effects of rimegepant on HRQoL have not been previously evaluated and were studied in a long-term open-label extension trial

• The objective of this study was to assess the effects of rimegepant 75 mg oral tablet on HRQoL over 52 weeks of use for the acute treatment of migraine

Objective

Introduction

ResultsSubjects

Conclusions•Acute treatment with rimegepant 75 mg was associated with clinically meaningful improvements in HRQoL by Week 12 across all domains and dosing regimens through Week 52

•Subjects in the rimegepant QOD+PRN enrollment group had the most pronounced gains in MsQOL scores at Week 12

•Observed changes exceeded the minimum clinically important difference by nearly 2-fold at all time points across all 3 domains

•Rimegepant may be associated with better overall function and reduced impairment of social- and work-related activities, favorably impacting healthcare costs, workplace productivity, and patient wellbeing

Figure 3. 12 to 52-Week Mean Improvement in MSQoL Scores Among PRN Subjects With 2 to 8 Attacks/Month

Acute Migraine Treatment with Rimegepant 75 mg and Health-Related Quality of Life in Migraine: Results from a Long-Term, Open-Label Safety Study Gilbert L’Italien, PhD1; Alexandra Thiry, PhD1; Robert Croop, MD1; Meghan Lovegren, BS1; Vladimir Coric, MD1; Kathryn Cowie1; David A. Stock, PhD1; Richard B. Lipton, MD21 Biohaven Pharmaceuticals, Inc., New Haven, CT; 2 Albert Einstein College of Medicine, Bronx, NY

Poster No. IHC-LB-023

References: 1. GBD 2016. Lancet Neurol. 2018;17:954-76; 2. Hazard E et al. Value Health. 2009;12:55-64; 3. Lipton RB et al. Headache. 2018;58:1336–37 (Poster #PS123LB); 4. Lipton RB et al. N Engl J Med. 2019;381:142-49; 5. Croop R et al. Lancet. 2019. doi: 10.1016/S0140-6736(19)31606-X; 6. Wagner TH et al. Headache. 1996;36:484-92; 7. Cole JC et al. Cephalalgia. 2009;29:1180–87. Disclosures This study was sponsored by Biohaven Pharmaceuticals. RBL has received honoraria and research support from Biohaven Pharmaceuticals and is also a stockholder. GL, AT, RC, VC, KC, and DAS are employed by and own stock/stock options in Biohaven Pharmaceuticals. Zydis is a registered trademark of R.P. Scherer Technologies, Inc. 19th International Headache Congress | September 5-8, 2019 | Dublin, Ireland

To download a copy of this poster, scan QR code.

• Of the 2867 subjects who entered the observation period, 1894 were enrolled in the treatment period, and 1784 were treated with rimegepant (PRN [n=1498], QOD+PRN [n=286])

• Most subjects (90%) were female; median age was 43 years; 3.6% of subjects were ≥65 years of age; and the median number of moderate to severe attacks per month was 6.0

• Mean (SD) 4-week rimegepant exposure was 7.7 (4.6) tablets; across the 52-week study period, total exposure was 105,192 rimegepant doses

• The HRQOL analyses included 1795 subjects at baseline, 1634 subjects at Week 12, 1215 subjects at Week 24, 1087 subjects at Week 36, and 920 subjects at Week 52

• The study population is an ongoing multicenter, open-label, long-term safety study (Study 201, NCT03266588) of rimegepant 75 mg oral tablet, comprising 3 cohorts based on historic monthly migraine attack frequency and 2 dosing regimens (Figure 1)

Methods

Figure 1. Study Design

• Aged ≥18 years, with ≥1-year history of ICHD-3 beta migraine• Two to 14 moderate or severe monthly migraine attacks; a subgroup with 4 to 14 moderate to severe

monthly attacks was assigned to QOD+PRN• If using preventive medication, dose stability was mandated for ≥3 months

Subjects

• Health-related quality of life (HRQoL) was assessed with the 14-item MSQ v.2.1 at baseline and Weeks 12, 24, 36, and 52

• Raw total scores were computed and rescaled from 0 to 100, with higher scores indicating better HRQoL; results were reported according to the 3 (RR, RP,EF) domains

Assessments

• Subjects were instructed to self-administer treatment as follows:– As needed (PRN) enrollment groups: rimegepant 75 mg up to once daily as needed to treat attacks

of any pain intensity for 52 weeks – Scheduled dosing group (QOD+PRN): rimegepant 75 mg every other day (QOD) supplemented by

PRN dosing on nonscheduled dosing days to treat attacks of any pain intensity for 12 weeks

Quality of Life• Mean MSQoL scores at baseline were 52.7 for RR, 67.9 for RP, and 60.9 for EF• By Week 12, rimegepant-treated subjects showed significant increases versus baseline in mean MSQoL

scores on the domains for RR (+14.5), RP (+11.5), and EF (+15.4) (P /AntiAliasGrayImages false /CropGrayImages true /GrayImageMinResolution 300 /GrayImageMinResolutionPolicy /OK /DownsampleGrayImages true /GrayImageDownsampleType /Bicubic /GrayImageResolution 300 /GrayImageDepth -1 /GrayImageMinDownsampleDepth 2 /GrayImageDownsampleThreshold 1.50000 /EncodeGrayImages true /GrayImageFilter /DCTEncode /AutoFilterGrayImages true /GrayImageAutoFilterStrategy /JPEG /GrayACSImageDict > /GrayImageDict > /JPEG2000GrayACSImageDict > /JPEG2000GrayImageDict > /AntiAliasMonoImages false /CropMonoImages true /MonoImageMinResolution 1200 /MonoImageMinResolutionPolicy /OK /DownsampleMonoImages true /MonoImageDownsampleType /Bicubic /MonoImageResolution 1200 /MonoImageDepth -1 /MonoImageDownsampleThreshold 1.50000 /EncodeMonoImages true /MonoImageFilter /CCITTFaxEncode /MonoImageDict > /AllowPSXObjects false /CheckCompliance [ /None ] /PDFX1aCheck false /PDFX3Check false /PDFXCompliantPDFOnly false /PDFXNoTrimBoxError true /PDFXTrimBoxToMediaBoxOffset [ 0.00000 0.00000 0.00000 0.00000 ] /PDFXSetBleedBoxToMediaBox true /PDFXBleedBoxToTrimBoxOffset [ 0.00000 0.00000 0.00000 0.00000 ] /PDFXOutputIntentProfile () /PDFXOutputConditionIdentifier () /PDFXOutputCondition () /PDFXRegistryName () /PDFXTrapped /False

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