Pfizer and Biohaven’s Vydura (Rimegepant) Receive EC's Marketing Authorization for the Treatment of Migraine and Prophylaxis of Episodic Migraine
Shots:
- The EC has granted marketing authorization for Vydura in adults with migraine with/out aura & prophylaxis of EM who have 4 migraine attacks/mos. The MAA was based on the 3 P-III & open-label studies along with a P-III study with a 1yr. OLE of Vydura for migraine
- The P-III study results showed that a single dose of rimegepant provides superior pain reduction & symptoms of migraine @2hr. while rimegepant (qod) showed a superior reduction in the no. of days/mos. @9 & 12wks. The therapy was maintained with continued dosing @12mos. OLE period
- The EC approval will be valid for all 27 EU member states, Iceland, Liechtenstein & Norway while assessment of MAA by MHRA is ongoing with expected approval in the UK shortly
Ref: Businesswire | Image: Pfizer
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