J&J: Janssen files renal drug application with FDA
(CercleFinance.com) - Johnson & Johnson said that US regulators have allowed its Janssen unit to file a new drug application for Invokana for the treatment of chronic kidney disease in patients with type-2 diabetes.
Janssen today announced the submission of a supplemental new drug application to the US Food and Drug Administration, seeking a new indication to reduce the risk of end-stage kidney disease, the doubling of serum creatinine, and renal or cardiovascular death in adults with type-2 diabetes and chronic kidney disease.
If approved, Invokana would become the first and only therapy in nearly 20 years that is indicated to reduce the risk of end-stage kidney disease when added to current standard of care.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
Janssen today announced the submission of a supplemental new drug application to the US Food and Drug Administration, seeking a new indication to reduce the risk of end-stage kidney disease, the doubling of serum creatinine, and renal or cardiovascular death in adults with type-2 diabetes and chronic kidney disease.
If approved, Invokana would become the first and only therapy in nearly 20 years that is indicated to reduce the risk of end-stage kidney disease when added to current standard of care.
Copyright (c) 2019 CercleFinance.com. All rights reserved.