Sanofi announced that the Food and Drug Administration (FDA) has approved Cablivi (caplacizumab-yhdp) for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
This is currently the only liquid formulation of this agent available in the US.
For individuals without cardiovascular disease, use of aspirin is associated with a reduced risk for cardiovascular events and an increased risk for major bleeding, according to a newly published meta-analysis.
The HERCULES (NCT02553317) study included 145 patients with aTTP who were randomized to receive either caplacizumab 10mg or placebo in conjunction with plasma exchange and immunosuppression.
Novartis announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for crizanlizumab (SEG101) for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease.
The study authors identified 43 case reports as well as 8 case series discussing drug-induced thrombocytosis.
The expanded approval was supported by data from the Phase 2 multicenter, single-arm CA180-372 study (NCT01460160) which included 78 pediatric patients with newly diagnosed B-cell precursor Ph+ ALL.
The researchers found that phlebitis was the most common complication (44%), followed by infiltration (16.3%), occlusion (7.6%), and catheter dislodgement (5.6%).
Andexxa was initially granted accelerated approval in May 2018 for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation was needed due to life-threatening or uncontrolled bleeding.
The BLA was supported by data from two Phase 3 trials (ADVANCE and RECOVER).
