NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 16h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYMDEKO is an oral, fixed-dose combination of tezacaftor and ivacaftor, two CFTR modulators developed by Vertex Pharmaceuticals for cystic fibrosis. It works by enhancing the function of defective CFTR protein in patients with specific CF mutations. The copackaged formulation simplifies dosing for patients requiring dual-modulator therapy.
Peak8.4 years to LOE
Peak lifecycle status indicates mature revenue streams and established team structures; career growth likely through specialization rather than rapid expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation
Started Jan 2013
35 enrolled
Cystic Fibrosis
Career Relevance
Working on SYMDEKO connects you to a peak-stage, market-leading rare disease therapy with strong commercial infrastructure and deep specialty care relationships. Career opportunities emphasize brand defense, managed care strategy, and specialist engagement rather than launch activities.
Brand Manager
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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.