Alnylam Reveals Receipt Of Complete Response Letter From FDA For Supplemental New Drug Application For Patisiran For Treatment Of Cardiomyopathy Of ATTR Amyloidosis
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Alnylam Pharmaceuticals has received a Complete Response Letter (CRL) from the FDA regarding its Supplemental New Drug Application for Patisiran, used for the treatment of cardiomyopathy of ATTR amyloidosis. The CRL does not affect the commercial availability of ONPATTRO, another drug approved by the FDA for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.
October 09, 2023 | 11:32 am
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Alnylam's new drug application for Patisiran has been responded to by the FDA with a CRL. This could potentially delay the drug's approval process, but it does not affect the availability of ONPATTRO.
The issuance of a Complete Response Letter (CRL) by the FDA usually indicates issues that need to be resolved before a drug can be approved. This could potentially delay the approval process for Patisiran, which could have a negative impact on Alnylam's stock in the short term. However, the CRL does not affect the commercial availability of ONPATTRO, which is already approved by the FDA.
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