Drugs / Orkambi
last change Jul 2023 re-read 3 minutes ago

Orkambi

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Orkambi — 2015-11-19 europa.eu ↗
Approved US (FDA) ORKAMBI — 2015-07-02 fda.gov ↗

Trials 0

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Comparator or background therapy1 trial
Phase 2 NCT02709109 Background Feb 2016 → Sep 2017 cystic fibrosis Parion Sciences Completed Missed primary

Press releases naming this drug 34 releases

DateIssuerRelease
2023-07-05 Vertex Pharmaceuticals Incorporated European Commission Approves ORKAMBI® (lumacaftor/ivacaftor) for the Treatment of Children With Cystic Fibrosis Ages 1 to <2 Years Old vrtx.com ↗
2023-04-27 Vertex Pharmaceuticals Incorporated Vertex Receives CHMP Positive Opinion for ORKAMBI® (lumacaftor/ivacaftor) in Children With Cystic Fibrosis Ages 1 to <2 Years Old vrtx.com ↗
2022-09-02 Vertex Pharmaceuticals Incorporated Vertex Announces U.S. FDA Approval for ORKAMBI® (lumacaftor/ivacaftor) in Children With Cystic Fibrosis Ages 12 to <24 months vrtx.com ↗
2021-06-25 Vertex Pharmaceuticals Incorporated Vertex Announces New Portfolio Reimbursement Agreement in Italy Including KAFTRIO®, SYMKEVI® and Additional Indications of ORKAMBI® and KALYDECO® for Eligible Patients With Cystic Fibrosis vrtx.com ↗
2020-04-21 Vertex Pharmaceuticals Incorporated Vertex Announces Innovative Reimbursement Agreement in Switzerland for ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for Eligible Cystic Fibrosis Patients vrtx.com ↗
2019-11-20 Vertex Pharmaceuticals Incorporated French Authorities Approve National Reimbursement of ORKAMBI® (lumacaftor/ivacaftor) for Eligible People Ages Two and Older With Cystic Fibrosis vrtx.com ↗
2019-10-21 Vertex Pharmaceuticals Incorporated Spanish Government Approves National Reimbursement of ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (tezacaftor/ivacaftor) in Combination With KALYDECO® (ivacaftor) vrtx.com ↗
2019-10-19 Vertex Pharmaceuticals Incorporated Vertex Announces Reimbursement of Cystic Fibrosis Medicines SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for Eligible Patients Ages 12 and Older, and ORKAMBI® (lumacaftor/ivacaftor) in Children Ages 2 to 5, With Certain CFTR Mutations in Australia vrtx.com ↗
2019-09-12 Vertex Pharmaceuticals Incorporated Vertex Announces New Access Agreement with Scottish Government for ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (tezacaftor/ivacaftor) vrtx.com ↗
2019-01-21 Vertex Pharmaceuticals Incorporated Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease vrtx.com ↗
2018-12-19 Vertex Pharmaceuticals Incorporated Vertex Announces it will Submit Cystic Fibrosis Medicines ORKAMBI® (lumacaftor/ivacaftor) as well as SYMKEVI® (tezacaftor/ivacaftor) to be Used in Combination with ivacaftor, to the Scottish Medicines Consortium for Appraisal vrtx.com ↗
2018-12-13 Vertex Pharmaceuticals Incorporated Health Canada Grants Market Authorization for ORKAMBI® (lumacaftor/ivacaftor) for Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease vrtx.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Orkambi ClinicalTrials.gov intervention name — accepted as the source's own label NCT02709109 ↗
Route Oral “orally every 12 hours” NCT02709109 ↗