Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
Padcev is a Nectin-4-directed antibody and microtubule inhibitor conjugate; Keytruda is a programmed death receptor-1-blocking antibody.
Erleada (apalutamide), an androgen receptor inhibitor, is now available in a 240mg tablet.
Pluvicto is indicated for patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane-based chemotherapy.
Letermovir is currently marketed under the brand name Prevymis for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic HSCT.
Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
The application is supported by data from the phase 3 EMPA-KIDNEY trial, which enrolled more than 6600 adults with CKD at risk of kidney disease progression.
The decision to withdraw the indication was made based on findings from the subsequent confirmatory phase 3 IMvigor130 trial.
According to a long-term safety study and a separate FDA internal study, Prolia had an increased risk of hypocalcemia in patients with advanced kidney disease on dialysis.
For patients who tolerated and remained on therapy, the average treatment effect on serum phosphorus was about -0.7mg/dL.
