Bayer: CHMP recommends approval of acoramidis
(CercleFinance.com) - Bayer announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion on the marketing of acoramidis for the treatment of transthyretin cardiac amyloidosis (TTCA).
The German pharmaceutical group points out that the CHMP's recommendation is based on the results of a Phase III placebo-controlled study, which showed that the tablet produced superior results in terms of both patient deaths and hospitalizations.
Amyloid transthyretin cardiomyopathy (ATTR-CM) is a rare, under-diagnosed, multi-organ disease which can be life-threatening.
The European Commission is expected to announce its final decision sometime next year.
In the United States, this small molecule developed by BridgeBio Pharma, for which Bayer holds the marketing rights for Europe, has already been approved by the Food and Drug Administration (FDA).
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