In phase 3 trials, the first agent in a novel class known as the selective cannabinoid type 1 receptor blockers doubled the odds of quitting smoking while reducing post-cessation weight gain compared with placebo. The agent, rimonabant, also improved several features of the metabolic syndrome in patients with abdominal obesity, reported researchers at the 53rd Annual Scientific Session of the American College of Cardiology (ACC).
FDA Issues Complete Response Letter for Onpattro in Heart Failure Indication
October 9th 2023Alnylam Pharmaceuticals will no longer pursue this indication of Onpattro and will instead on focus on a label expansion for Amvuttra, which is in phase 3 development to treat patients with cardiomyopathy of ATTR amyloidosis.
FDA Advisory Committee Backs Use of Onpattro in Heart Failure Indication
September 16th 2023Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.