Alnylam Pharmaceuticals (ALNY.O) said on Monday it would not pursue expanded use of its drug to treat a potentially fatal heart disease in the U.S. after the Food and Drug Administration declined to approve the medication despite a favorable recommendation from its advisers.
said on Monday it would not pursue expanded use of its drug to treat a potentially fatal heart disease in the U.S. after the Food and Drug Administration declined to approve the medication despite a favorable recommendation from its advisers.
The rejection was a rare instance of the regulator going against its advisory panel's backing for a drug. The FDA's outside panel of experts had last month"We are surprised" by the FDA's decision, RBC capital analyst Luca Issi said in a note. Alnylam said it will focus on another drug candidate, vutrisiran, an under-the-skin injection in late-stage trials to treat ATTR amyloidosis-related cardiomyopathy.
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