SPONSORED CONTENT: Morie Gertz, MD, reviews data on the use of birtamimab plus standard-of-care anti-plasma cell chemotherapy in patients with light-chain amyloidosis, which was investigated in the phase 3 randomized, placebo-controlled VITAL trial.
In a complete response letter, the FDA said the clinical meaningfulness of patisiran s effects in cardiomyopathy of ATTR amyloidosis are not established, despite good reviews from an advisory panel.