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deutivacaftor; tezacaftor; vanzacaftor

Generic: DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM·Brand: ALYFTREK

deutivacaftor; tezacaftor; vanzacaftor: sourced relationships with 1 company · 1 FDA decision.

deutivacaftor; tezacaftor; vanzacaftor evidence translation

What we can confirm

What it means

Source-backed records connect deutivacaftor; tezacaftor; vanzacaftor to VRTX; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could deutivacaftor; tezacaftor; vanzacaftor → VRTX affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Dated Pipeline Records (2)
CompanyDated record stage
VERTEX PHARMACEUTICALS INC / MA (VRTX)
Reported 2024-12-20 · Current development: unknownSource
Approved
VERTEX PHARMACEUTICALS INC / MA (VRTX)
Reported 2024-12-20 · Current development: unknownSource
Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 5 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. ALYFTREK is a combination of deutivacaftor, a CFTR potentiator, tezacaftor, and vanzacaftor indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 6 years and older who have a clinical diagnosis of CF and who have at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. ( 1 , 12.1 ) If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. ( 1 )(VRTX)FDA ↗
NDA218730Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet

Frequently asked questions

Which companies have sourced relationships with deutivacaftor; tezacaftor; vanzacaftor?

deutivacaftor; tezacaftor; vanzacaftor has dated SEC/FDA relationship records for VERTEX PHARMACEUTICALS INC / MA.

What is deutivacaftor; tezacaftor; vanzacaftor's latest FDA decision?

The most recent tracked FDA decision for deutivacaftor; tezacaftor; vanzacaftor is Approval for 1 INDICATIONS AND USAGE ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 5 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. ALYFTREK is a combination of deutivacaftor, a CFTR potentiator, tezacaftor, and vanzacaftor indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 6 years and older who have a clinical diagnosis of CF and who have at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. ( 1 , 12.1 ) If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. ( 1 ), dated December 20, 2024.