To Evaluate the Long-term Safety and Tolerability of Acoramidis in Participants With Newly Diagnosed ATTR-CM (ACT-EARLY OLE)

Korábbi kezelés

• Participants who completed the AG10-501 study with a diagnosis of ATTR-PN only or who permanently discontinued study drug prior to diagnosis of ATTR-CM in AG10-501.
• Major surgery planned during the next 6 months (some exceptions).

Más betegség

• History of light-chain amyloidosis (AL) or another non-TTR amyloid subtype (eg, ApoA-1, gelsolin).
• Stage IV or V chronic kidney disease.
• Active malignancy, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix that has been successfully treated.
• History of any organ transplant (with the exception of corneal transplant).
• Known hypersensitivity to acoramidis or any of its excipients.

Laborértékek

• History of a monoclonal paraprotein or abnormal light chains in serum or urine (ie, monoclonal gammopathy of undetermined significance, MGUS) in which AL has not been ruled out.

Egyéb

• Treatment of ATTR-CM with any ATTR-oriented on- or off-label or OTC product.

• Participants must have completed the AG10-501 study (ACT-EARLY study) within the past 60 calendar days with a diagnosis of ATTR-CM (based on the AG10-501 protocol definition of ATTR-CM).