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Pfizer and Biohaven’s Vydura (Rimegepant) Receive EC's Marketing Authorization for the Treatment of Migraine and Prophylaxis of Episodic Migraine

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Pfizer and Biohaven’s Vydura (Rimegepant) Receive EC's Marketing Authorization for the Treatment of Migraine and Prophylaxis of Episodic Migraine

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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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