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 Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYMDEKO is an oral copackaged combination of tezacaftor and ivacaftor, two CFTR modulators developed by Vertex Pharmaceuticals for cystic fibrosis. It represents a dual-action small molecule approach to restore CFTR protein function in patients with specific genetic mutations. The combination targets both defective CFTR processing and gating to improve lung function and clinical outcomes.
Peak8.9 years to LOE
Product is in peak commercial phase with 207 linked job openings, indicating active brand team expansion and revenue optimization efforts.
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
SYMDEKO supports a robust talent ecosystem across Vertex with 207 linked positions spanning commercial, R&D, regulatory, and engineering functions. Working on this peak-stage product offers visibility into managed-care strategy, patient access programs, and manufacturing optimization while remaining positioned within Vertex's leading CFTR franchise.
Director
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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.