Product attributes
Symdeko™ (tezacaftor/ivacaftor and ivacaftor) is a combination drug indicated for the treatment of cystic fibrosis (CF) in people aged 12 years and above.
The drug was developed by Vertex Pharmaceuticals. The new drug application (NDA) for Symdeko™ was accepted for review by the US Food and Drug Administration (FDA) in August 2017 and it was given priority review designation. The drug was approved by the FDA in February 2018.
Vertex has also submitted a marketing authorisation application (MAA) for Symdeko™ to the European Medicines Agency (EMA). The company expects approval for the drug in Europe by the second half of 2018.
Symdeko’s mechanism of action
Symdeko™ contains a combination of tezacaftor and ivacaftor. Tezacaftor moves the defective CFTR protein onto the cell surface, while ivacaftor helps to facilitate the opening of the chloride channel on the cell surface to increase chloride transport.
The drug is available in 150mg dose tablets for oral administration.
