Articles related to FDA

Hutchmed’s submission was based primarily on two phase 3 trials conducted in China. Even though a bridging study conducted in the US that suggested safety and efficacy similar to that observed in the Chinese study population, FDA responded that a multiregional clinical trial “more representative of the US patient population and in accordance with US medical practice will be required” for resubmission.

Mounjaro (tirzepatide) is a first-in-class, once-weekly, dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule. It enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucose-dependent manner. The FDA approval of Mounjaro as an adjunct therapy to diet and exercise for adults with type 2 diabetes was based on clinical trials where treatment with Mounjaro resulted in statistically significant reduction in both A1c and weight vs. semaglutide, insulin degludec, and insulin glargine.

An FDA expert panel voted 16-0, with one abstention, recommending that future FDA approvals of PI3K inhibitors be supported by randomized data. The four currently-approved PI3K inhibitors for treating hematologic malignancies received FDA approval based on single-arm data. Although these drugs have offered durable ORR and improvements in PFS, randomized data presented at the hearing showed they are associated with higher rates of serious adverse events, including fatality.

The US Food and Drug Administration (FDA) has said “no” to Akebia Therapeutics’ drug application for vadadustat, a therapy to treat anemia due to chronic kidney disease. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. The FDA cited safety concerns as the main reason for it rejecting the application.

The FDA has withdrawn its authorization for use of the monoclonal antibody sotrovimab in the treatment of COVID-19 in regions with a high frequency of the Omicron BA.2 subvariant. Data show that the authorized dose of the monoclonal antibody — 500 mg — is unlikely to be effective against the BA.2 COVID-19 subvariant.

Orexin receptor antagonists work by suppressing the wake drive through blocking wake-promoting neuropeptides. Daridorexant is the third dual-orexin inhibitor to receive FDA approval for people with difficulty in sleep onset or sleep maintenance.