Shots: The NICE has recommended Novartis’ Adakveo (crizanlizumab) as a new treatment option to prevent recurrent sickle cell crises in patients aged ≥16 Additionally, patients will now have access to […]readmore
Tags : crizanlizumab
Shots: The US FDA’s approval is based on SUSTAIN study assessing Adakveo (5mg/kg, 2.5mg/kg) vs PBO in 198 patients in a ratio 1:1:1 aged ≥ 16yrs. with any genotype of […]readmore
Shots: The US FDA has accepted Novartis’ BLA and has granted Priority Review for crizanlizumab to prevent vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD) The FDA submission […]readmore
Regulatory
Novartis’s SEG101(crizanlizumab) Receives FDA’s Breakthrough Therapy(BT) Designation for Sickle Cell
Shots: The BTD is based on P-II SUSTAIN study results assessing crizanlizumab (5 mg/kg) vs PBO in patients with/without hydroxyurea therapy for preventing vaso-occlusive crises(VOCs) in SCD P-II SUSTAIN study […]readmore