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Biohaven’s migraine nasal spray zavegepant is set to generate annual sales of $206.8 million in the US following the potential approval of its NDA, which was received by the FDA last week, according to GlobalData. The leading data and analytics company notes that the drug’s alternative delivery offers it a competitive advantage, but key opinion leaders (KOLs) previously interviewed by GlobalData have voiced concerns over nasal spray side effects and reimbursement.
Christie Wong, Pharma Analyst at GlobalData, comments: “If approved, not only will zavegepant be the first non-oral formulation of calcitonin gene-related peptide receptor (CGRP) antagonist in Biohaven’s migraine portfolio, but it will be the first (and only) intranasal treatment in the gepant drug class. GlobalData expects that there will be an increased prescription of CGRP antagonists, gepants, as acute migraine treatments in the coming years, and this drug class will claim patient shares throughout the 7MM**. This will contribute towards zavegepant’s strong expected sales performance.”
According to GlobalData’s latest report, ‘Migraine Drug Market Size, Share & Trends Analysis and Forecast by Strategic Competitor Assessment, Market Characterization, Unmet Needs, Clinical Trial Mapping and Implications 2020 – 2030’, zavegepant’s intranasal formulation will give it a competitive edge, as this convenient delivery method would benefit patients that can’t take competing oral gepants such as AbbVie’s Ubrelvy or Biohaven’s own Nurtec due to migraine-related nausea and dysphagia (difficulty swallowing). However, KOLs interviewed by GlobalData shared some concerns about side effects unrelated to the medication itself, but invariably present in nasal sprays.
Wong continues: “KOLs have identified concerns around nasal sprays, including congestion, post-nasal drip and that they can leave a bad taste in the back of the throat. Furthermore, they worried about potential reimbursement issues that may impact patients’ access due to the higher annual costs of therapy of nasal sprays in comparison to oral tablets. Thus, solid marketing and market access schemes are required to set zavegepant apart from competitors in a crowded market and to convince payers to reimburse it.”
Biohaven is a strong player in the migraine market, with an extensive CGRP-targeting portfolio of small molecules—including Nurtec, intranasal zavegepant, and five preclinical CGRP assets. In addition, an oral formulation of zavegepant is in Phase II/III development for migraine prevention. Earlier this month, Pfizer proposed an acquisition of Biohaven and its CGRP program at a value of $12.2 billion. If completed, this acquisition will significantly support the development and commercialization of the company’s migraine products.
* NDA = new drug application
** 7MM = US, Japan, France, Germany, Italy, Spain, and the UK
