Pfizer Has Tafamidis Data In Hand, But Market Development Still A Challenge
Unveiling its Phase III data showing both an all-cause mortality and cardiovascular hospitalization benefit, Pfizer thinks it can bring dramatic improvement in therapy for transthyretin cardiomyopathy.
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Tafamidis was approved by FDA in two formulations that will be marketed as Vyndaqel and Vyndamax for the treatment of transthyretin amyloid cardiomyopathy.
Pivotal studies of the first two drugs approved for treating hereditary transthyretin-mediated amyloidosis did not provide cardiac efficacy data on how patients feel, function or survive, reviewers said; the agency approved Alnylam’s patisiran and Ionis’ inotersen for patients with the polyneuropathy form of the disease but not the cardiomyopathy form.