Novartis crizanlizumab wins speedy FDA review, putting it closer to blockbuster sickle cell launch
Novartis plan to launch over 10 potential blockbuster drugs or new indications by 2021 is quickly unfolding. The FDA has accepted a biologics application for the pharma giant's sickle cell disease candidate crizanlizumab (SEG101) and put the drug under priority review, which slashes four months off its evaluation time to just six months in total, the company said Tuesday. If approved, it could sit alongside multiple sclerosis drug Mayzent, spinal muscular atrophy gene therapy Zolgensma and age-related macular degeneration candidate brolucizumab—which also under priority review—among the Swiss drugmaker's most important launches these days. But several competitors are not far behind. Crizanlizumab, a drug Novartis got via its acquisition of Selexys Pharmaceuticals in 2016, is designed to prevent vaso-occlusive crises (VOCs), the painful events resulting from blood vessel blockage in sickle cell disease patients. The drug reduces clusters of cells that block blood flow by targeting the P-selectin protein. In a phase 2 study, crizanlizumab, given once monthly, cut the median rate of VOCs that required healthcare visits by 45.3% in a year versus placebo. What’s more, more than double the number of crizanlizumab patients didn’t experience any VOCs at all. The reductions were seen in patients with or without the use of the old standard treatment hydroxyurea, according to Novartis.