A study presented on August 25 at the 20th International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Bordeaux, France, revealed that higher-dose rofecoxib (>25 mg/d) was associated with a greater risk of acute myocardial infarction (AMI) and sudden cardiac death (SCD) compared to other NSAIDs. The risk of AMI and SCD was also increased with lower-dose rofecoxib (25 mg/d) when compared with celecoxib. The maximum recommended daily doses of rofecoxib in the management of pain associated with osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and migraine attacks with or without aura are 25, 25, 50, and 50 mg/d, respectively.
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.