Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF).
This is currently the only liquid formulation of this agent available in the US.
In the ERASURE, FIXTURE, FEATURE, and JUNCTURE trials, psoriasis patients who reported problems in these quality of life measures (through the EQ-5D-3L questionnaire) were randomized to receive secukinumab 300mg or placebo and were assessed at weeks 4, 8, and 12.
Metoprolol tartrate is indicated for the treatment of hypertension, for the long-term treatment of angina pectoris, and for the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality.
Prior to treatment, HER2 testing using FDA-approved tests should be performed.
The FDA takes the advice of the panel into consideration when making decisions, however it is not bound by their recommendations.
Products covered under the Clozapine REMS program include Clozaril (HLS Therapeutics), Fazaclo (Jazz), and Versacloz (TruPharma), in addition to all generic versions.
In the Biologics License Application (BLA) resubmission, Amgen and UCB proposed to narrow the indication to treatment of osteoporosis in postmenopausal women at high risk of fracture.
The approval of the HCC indication was based on data from the Phase 3 CELESTIAL trial (N=707) which randomized patients who previously received sorafenib to either Cabometyx or placebo.