The tafamidis Phase III Transthyretin Cardiomyopathy (ATTR-ACT) study evaluating tafamidis for the treatment of transthyretin cardiomyopathy has met its primary endpoint, demonstrating a statistically-significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo at 30 months.
The preliminary safety data showed that tafamidis was generally well tolerated in this population and no new safety signals were identified, said US pharma giant Pfizer (NYSE), which already markets the drug in Europe and some other countries (though not the USA) under the Vyndaqel trade name for the treatment of the rare disease transthyretin amyloid polyneuropathy (TTR-FAP).
"A very rare late stage pipeline surprise," says analyst
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