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February 28, 2022updated 17 Mar 2022 3:58am

Vydura gains positive CHMP nod for migraine, but faces tough competition ahead

Vydura will become the first CGRP receptor antagonist available in Europe if approved by the European Medicines Agency (EMA).

By GlobalData Healthcare

On February 25, Biohaven and Pfizer announced that Vydura (rimegepant) had received a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) in the acute and preventative treatment of migraine. If approved by the EMA, Vydura, which is marketed in the US as Nurtec, will become the first oral calcitonin gene-related peptide (CGRP) receptor antagonist to become available in Europe. However, the drug’s market entry will be followed closely by AbbVie’s CGRP receptor antagonist, Qulipta (atogepant), which will prove to be a fierce competitor in the migraine prophylaxis space.

Despite a likely first-to-market advantage for Vydura in Europe, GlobalData anticipates the drug will face potent competition from AbbVie’s Qulipta, which is expected to enter European markets in 2023. Key opinion leaders (KOLs) interviewed by GlobalData were impressed with Qulipta’s exceptional migraine prevention rates and lauded its availability in three strengths for easy dose titration. Compared to Qulipta, Vydura has the added benefit of both acute and preventative treatment indications. However, KOLs noted that gepants had limited utility in the acute treatment of migraine. They explained that gepants are generally quite slow in their onset of action, and are thus less optimal for acute pain relief, particularly when compared to inexpensive generic triptans. Based on these factors, GlobalData forecasts Vydura and Qulipta to reach sales of $35.4 million and $57.1 million, respectively, by 2030 in the five major European markets (5EU) (France, Germany, Italy, Spain, and the UK).

Across the seven major pharmaceutical markets (7MM) (US, 5EU, and Japan), GlobalData anticipates migraine market sales of $652.1 million for Nurtec/Vydura in 2030, representing nearly 22% of total sales within the growing oral CGRP inhibitor class. Likely in a bid to set it apart from competitors, Biohaven has plans for Nurtec/Vydura outside of the neurology space. In January 2021, in collaboration with Weill Cornell Medical College, the company started a Phase II pilot study of Nurtec in the treatment of plaque psoriasis. More recently, the company announced the start of a new Phase II/III trial (NCT05248997) of Nurtec in the treatment of chronic rhinosinusitis. These two disease markets are sizeable and could greatly expand Nurtec’s reach if the drug is found to be efficacious.

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