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Monthly migraine days (MMD)

Neurologyยท appears in 277+ cited findings in this library

What it is and how the reviews use it

Monthly migraine days (MMD) is an endpoint used in regulatory review documents to quantify the frequency of migraine headaches experienced by patients. It measures the number of days in a month that a patient experiences a migraine. The FDA review for AbbVie Inc.'s Atogepant (NDA215206, ORIG 1, 2021, p.23) defines a reduction in mean monthly migraine days as ranging from 0.7 to 1.7 days.

Regulatory reviews frequently use MMD to assess the efficacy of new treatments. For instance, the H. Lundbeck A/S Vyepti FDA Review (BLA761119, ORIG 1, 2020, p.58) reported a mean change from baseline in monthly migraine days of -4.3. Similarly, the Eli Lilly and Company Emgality FDA Review (BLA761063, ORIG 1, 2018, p.194) noted a reduction in monthly migraine days of 4-5 days. The Novartis AG Aimovig EMA EPAR public assessment report (EMEA/H/C/0044, p.58) presented a common odds ratio for >=50% reduction in monthly migraine days vs placebo of 1.74.

Real examples โ€” cited to the source page

Novartis AG โ€” AimovigCommon odds ratio for >=50% reduction in monthly migraine days vs placebo1.74Aimovig EMA EPAR, p.58
H. Lundbeck A/S โ€” VyeptiMean change from baseline in monthly migraine days-4.3Vyepti FDA Review, p.58
AbbVie Inc. โ€” AtogepantNumber of monthly migraine days observations for exposure-response analysis6471Atogepant FDA Review, p.183
Eli Lilly and Company โ€” EmgalityReduction in monthly migraine days4-5Emgality FDA Review, p.194
Fulcrum Therapeutics, Inc. โ€” BocunebartBocunebart MMD reduction vs placebo-2.3SEC 8-K, p.15
AbbVie Inc. โ€” AquiptaAdjusted p-value for atogepant 30 mg QD vs. placebo for monthly migraine days<.0001Aquipta EMA EPAR, p.81
Teva Pharmaceutical Industries Limited โ€” AjovyReduction in monthly migraine days or moderate to severe headache days compared to placebo2Ajovy FDA Review, p.155
Pfizer Inc. โ€” VyduraNet difference in monthly migraine days (MDs) vs placebo-1.2Vydura EMA EPAR, p.94

Different drugs were studied in different trials โ€” these values are not head-to-head comparisons.

Explore the full evidence

Every Monthly finding in the library โ€” searchable and answerable in plain language โ€” is in the Neurology research library โ†’

Figures are as stated in the cited source documents. Educational reference only โ€” not medical or investment advice.

Monthly migraine days (MMD) โ€” Explained with Cited FDA & EMA Examples | BioPharmaPT Neurology