US-based Pfizer’s (NYSE: PFE) Nurtec ODT (rimegepant), the world’s first calcitonin gene-related peptide (CGRP) receptor antagonist in rapidly dissolving oral disintegrating tablet form, has become available to patients in China via the Bo’Ao Lecheng Medical Tourism Pilot Zone in Hainan from January 1. The drug is being launched in Hainan through the Hainan branch of Shanghai’s Ruijin Hospital.
Clinical Profile and Regulatory History
Rimegepant was first approved in the US in February 2020 for the acute treatment of migraine with or without aura in adults. In May 2021, it received additional approval for the prevention and treatment of paroxysmal migraine. The drug’s Phase III clinical study in the Asia Pacific region, which included Chinese and South Korean subjects, yielded positive topline data in February of last year, demonstrating significant efficacy and good safety.
Availability in China
The availability of Nurtec ODT in China via the Bo’Ao Lecheng Medical Tourism Pilot Zone marks a significant step in expanding access to innovative migraine treatments. This initiative underscores Pfizer’s commitment to bringing advanced therapies to patients in need, leveraging the unique regulatory environment of the Bo’Ao Lecheng zone to accelerate the introduction of new drugs.
Future Outlook
The launch of Nurtec ODT in China highlights Pfizer’s ongoing efforts to address significant unmet needs in migraine treatment. With its demonstrated efficacy and safety profile, rimegepant is poised to make a meaningful impact on patient outcomes. Pfizer’s strategic approach to introducing the drug in China via the Bo’Ao Lecheng zone further solidifies its position as a leader in the global pharmaceutical industry.-Fineline Info & Tech