Rimegepant (2) – Vydura®

• Clinical trials
  • The CHALLENGE-MIG study enrolled adults with migraine, with or without aura, who had an average of 4 to 14 migraine headache days and at least 2 migraine attacks per month in the 3 months prior to the first study visit, as well as during the prospective baseline phase.
  • The study compared the administration of rimegepant with that of galcanezumab.

a) Adults with at least 4 migraine attacks per month who have an indication for preventive treatment of episodic migraine and who are suitable candidates for conventional migraine prophylactic treatments

• An additional benefit is not proven.
• For patient population a), no data are available to assess the additional benefit of rimegepant compared with the appropriate comparator therapy. Accordingly, the additional benefit of rimegepant compared with the appropriate comparator therapy in this patient group is not proven.

b) Adults with at least 4 migraine attacks per month who have an indication for preventive treatment of episodic migraine, who do not respond to any of the pharmacological therapies/classes of active substances (amitriptyline, flunarizine, metoprolol, propranolol), do not respond to them, are unsuitable for them or cannot tolerate them

• The additional benefit is not proven.
• The pharmaceutical manufacturer presents, for patient group b), the results of the CHALLENGE-MIG study (comparison of rimegepant versus galcanezumab) and, in addition, the results of the registration study BHV3000-305 (comparison of rimegepant versus placebo). In agreement with the pharmaceutical manufacturer, the BHV3000-305 study is not suitable for benefit assessment of rimegepant in this therapeutic indication due to the lack of a comparison with the appropriate comparator therapy.
• Overall, however, the information provided on the study does not indicate whether, and if so how many, of the patients in the study correspond to patient population b). Consequently, the results of the CHALLENGE-MIG study as presented are not suitable for the benefit assessment of rimegepant in patient group b).
• Neither study is suitable for benefit assessment of rimegepant in patient group b), as the appropriate comparator therapy was not implemented (study BHV3000-305) or the study population does not correspond to patient population b) (CHALLENGE-MIG study). Consequently, the additional benefit of rimegepant over the appropriate comparator therapy in this patient population is not proven.

Courtesy translation only, please refer to the German original.