| 2020-12-21 |
Vertex Pharmaceuticals Incorporated |
Regulatory Vertex Announces FDA Approvals of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Use in People With CF With Certain Rare Mutations vrtx.com ↗
SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) also received approvals to include additional responsive mutations in people with CF ages 6 years and older and age 4 months and older, respectively. |
| 2020-09-01 |
Vertex Pharmaceuticals Incorporated |
Regulatory FDA Accepts Vertex’s Supplemental New Drug Applications for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Additional CFTR Mutations vrtx.com ↗
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| 2019-10-19 |
Vertex Pharmaceuticals Incorporated |
Regulatory 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 ↗
Following previously received positive recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), eligible patients in Australia will be able to access both medicines immediately, and the medicines will be listed on the Pharmaceutical Benefits Scheme (PBS) from December 1st. |
| 2019-06-21 |
Vertex Pharmaceuticals Incorporated |
Regulatory FDA Approves SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene vrtx.com ↗
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| 2019-03-06 |
Vertex Pharmaceuticals Incorporated |
Results Two Phase 3 Studies of the Triple Combination of VX-445, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that treatment with the triple combination of the next-generation corrector VX-445, tezacaftor and ivacaftor resulted in statistically significant improvements in lung function (percent predicted forced expiratory volume in one second, or ppFEV1) in two Phase 3 studies in people with cystic fibrosis (CF). |
| 2019-02-14 |
Vertex Pharmaceuticals Incorporated |
Results Positive Phase 3 Study for Tezacaftor/Ivacaftor Combination in Children Aged 6-11 Years with Cystic Fibrosis Supports European Medicines Agency Submission vrtx.com ↗
The study met its primary endpoint of absolute change in lung clearance index (LCI2.5) through 8 weeks of treatment, demonstrating a statistically significant improvement in LCI2.5 among patients treated with tezacaftor/ivacaftor. |
| 2018-11-27 |
Vertex Pharmaceuticals Incorporated |
Results Two Phase 3 Studies of the Triple Combination of VX-659, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis vrtx.com ↗
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| 2018-11-01 |
Vertex Pharmaceuticals Incorporated |
Regulatory Vertex Announces European Authorization for Third Cystic Fibrosis Medicine SYMKEVI® (tezacaftor/ivacaftor), to be used in combination with ivacaftor (KALYDECO®), for People with CF Aged 12 and Older with Certain Mutations in the CFTR gene vrtx.com ↗
With today’s Marketing Authorization, we are rapidly moving towards treating 90 percent of CF patients. |
| 2018-10-18 |
Vertex Pharmaceuticals Incorporated |
Results Vertex Data Presented at North American Cystic Fibrosis Conference (NACFC) Demonstrate Rapid Progress Toward Expanding and Enhancing Options for Treating the Underlying Cause of Cystic Fibrosis vrtx.com ↗
Data from these studies were also published online today in The New England Journal of Medicine (NEJM). |
| 2018-07-27 |
Vertex Pharmaceuticals Incorporated |
Regulatory Vertex Receives European CHMP Positive Opinion for SYMKEVI® (tezacaftor/ivacaftor) for People with Cystic Fibrosis Aged 12 and Older with Certain Mutations in the CFTR Gene vrtx.com ↗
Today’s announcement is a pivotal accomplishment along that journey. |
| 2018-06-28 |
Vertex Pharmaceuticals Incorporated |
Regulatory Health Canada Approves PrSYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene vrtx.com ↗
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| 2018-06-07 |
Vertex Pharmaceuticals Incorporated |
Results Vertex Data Presented at European Cystic Fibrosis Society (ECFS) Conference Demonstrate Early and Long-Term Disease-Modifying Potential of Treating the Underlying Cause of CF vrtx.com ↗
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