NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
SYMDEKO (COPACKAGED) (tezacaftor and ivacaftor) by Vertex Pharmaceuticals is (including f508del-cftr) to increase the amount of mature cftr protein delivered to the cell surface. Approved for cystic fibrosis (cf) in patients aged 6 years, older. First approved in 2018.
Drug data last refreshed 8h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYMDEKO is an oral copackaged combination of tezacaftor and ivacaftor, two small-molecule CFTR modulators developed by Vertex Pharmaceuticals for cystic fibrosis. The drug works by improving the function and localization of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. It is indicated for patients with specific CFTR mutations who benefit from dual modulation therapy.
Peak8.6 years to LOE
Product is in peak revenue stage with established market presence; commercial teams are focused on maintaining market share and optimizing patient access programs.
Mechanism of Action
(including F508del-CFTR) to increase the amount of mature CFTR protein delivered to the cell surface. Ivacaftor is a CFTR potentiator that facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein at the cell surface. For ivacaftor to…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.