Novartis: gets FDA priority review for neuromuscular disease
(CercleFinance.com) - Swiss drugmaker Novartis has won the US Food and Drug Administration's priority review status for a one-time treatment designed to address the genetic root cause of Type 1 spinal muscular atrophy, a progressive neuro-muscular disease that mostly affects children.
The decision is expected in May 2019, Novartis said.
The company has also announced longer-term data from two pivotal clinical trials on Kymriah, showing that durable responses were maintained in patients with advanced blood cancers.
Novartis also presented positive real-world evidence study in patients with immune thrombocytopenia treated with Revolade compared to other second-line therapies.
Finally, new data from a post hoc analysis of a Phase II study on crizanlizumab - a once-a-month monoclonal antibody infusion being investigated for the treatment of sickle cell disease - showed greater reductions of crises, Novartis said.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The decision is expected in May 2019, Novartis said.
The company has also announced longer-term data from two pivotal clinical trials on Kymriah, showing that durable responses were maintained in patients with advanced blood cancers.
Novartis also presented positive real-world evidence study in patients with immune thrombocytopenia treated with Revolade compared to other second-line therapies.
Finally, new data from a post hoc analysis of a Phase II study on crizanlizumab - a once-a-month monoclonal antibody infusion being investigated for the treatment of sickle cell disease - showed greater reductions of crises, Novartis said.
Copyright (c) 2018 CercleFinance.com. All rights reserved.