Drugs and Companies using IVACAFTOR ingredient

Market Authorisation Date: 17 March, 2015

Treatment: Treatment of a moderate mild clinical phenotype of cf using ivacaftor in a patient age 6 months to <6 years who has one cftr mutation repsonsive to ivacaftor based on clinical and/or in vitro assay data; Use of ivacaftor for treating cystic fibrosis in a patient with a mild to moderate cf phenotype with at least one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data; Treatment of a moderate to mild clinical phenotype of cf using ivacaftor in a patient age 4 months to <6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data; Method of treating cystic fibrosis; Treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has a r117h mutation in the cftr gene; Method of treating a patient having cystic fibrosis, the patient having a r117h mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide; Treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has a r117h mutation in the cftr gene; Treatment of cf in a patient age 6 months to < 6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor; Treatment of cf in a patient age 4 months to <6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor; Method of treating a patient having cystic fibrosis, such as a patient having a g551d mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide; Treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data; Treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data; Treatment of cf in a patient age 6 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 10272046; Treatment of cf in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 10272046; Treatment of cf in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 11147770

Dosage: GRANULE;ORAL

Drugs and Companies using IVACAFTOR; LUMACAFTOR ingredient

Market Authorisation Date: 07 August, 2018

Treatment: Method of treating cystic fibrosis using n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and 3-(6-(1-2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid; Method of treating cystic fibrosis in a patient, the patient having the f508del mutation in cftr, using ivacaftor and lumacaftor; Method of treating cystic fibrosis in patients who are homozygous for the f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene; Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the f508del mutation in the cftr gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor; Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor; Method of treating cystic fibrosis; Method of treating cystic fibrosis in a patient, the patient having the f508del mutation in cftr, using ivacaftor and form i lumacaftor; Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the f508del mutation in the cftr gene using the tablet according to claim 1 of u.s. patent no. 11,052,075, where the tablet further comprises ivacaftor; Treatment of cystic fibrosis in a patient age 12 years or older who is homozygous for the f508del mutation in the cftr gene using the tablet comprising lumacaftor as recited in claim 1, 19, or 21 of u.s. patent no. 10,076,513 and ivacaftor; Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the f508del mutation in the cftr gene using the dosage unit comprising lumacaftor and ivacaftor as recited in claim 1 of us patent 9192606; Method of treating cystic fibrosis in a patient, the patient having the f508del mutation in cftr, using the dosage unit of claim 1 of u.s. patent no. 8,716,338; Method of treating cystic fibrosis in patients who have the f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.; Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the f508del mutation in the cftr gene using a pharmaceutical composition according to claim 2 of u.s. patent no. 10,597,384, further comprising ivacaftor

Dosage: GRANULE;ORAL

Drugs and Companies using IVACAFTOR; IVACAFTOR, TEZACAFTOR ingredient

NCE-1 date: February, 2022

Market Authorisation Date: 12 February, 2018

Treatment: Tezacaftor and ivacaftor for the treatment of patients with a mild to moderate clinical phenotype of cystic fibrosis having at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence; Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients age 6 years and older who have a r117h mutation in the cftr gene; Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the f508del mutation or having at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence; Treating cystic fibrosis patients ages 6 and older, who are homozygous for f508del or have at least 1 cftr gene mutation responsive to tezacaftor/ivacaftor, with tezacaftor and a solid composition comprising amorphous (<30% crystalline) ivacaftor; Treating cystic fibrosis patients ages 12 and older, who are homozygous for f508del or have at least 1 cftr gene mutation responsive to tezacaftor/ivacaftor, with tezacaftor and a solid composition comprising amorphous (<30% crystalline) ivacaftor; Treatment of cystic fibrosis in patients aged 12 and older, who are homozygous for the f508del mutation or have at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients aged 6 and older, who are homozygous for the f508del mutation or have at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older, who are homozygous for the f508del mutation or heterozygous for f508del and a second cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older, who are homozygous for the f508del mutation or heterozygous for f508del and a second cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients age 12 and older, who have two copies of the f508del mutation or who have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; Treatment of cystic fibrosis in patients ages 6 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; Treatment of cystic fibrosis in patients age 6 and older, who have two copies of the f508del mutation or who have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; Treatment of cystic fibrosis in patients ages 12 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; Treatment of cystic fibrosis in patients 12 years and older, with a f508del or g551d cftr gene mutation and a a455e, 2789+5g->a, or 3849+10kbc->t mutation, comprising concurrent coadministration of the compositions of claim 1 of u.s patent 10058546; Treatment of cystic fibrosis in patients 6 years and older, with a f508del or g551d cftr gene mutation and a a455e, 2789+5g->, or 3849+10kbc->t mutation, comprising concurrent coadministration of the compositions of claim 1 of u.s. patent 10058546; Treatment of cf in patients 6 years and older who have a f508del or g551d cftr mutation and a 2nd mutation selected from r117h, a455e, 2789+5g->a, and 3849+10kbc->t, comprising concurrent coadministration of the compositions of claim 1 of us 10058546; Treatment of cf in patients 12 years and older who have a f508del or g551d cftr mutation and a 2nd mutation selected from r117h, a455e, 2789+5g->a, & 3849+10kbc->t, comprising concurrent coadministration of the compositions of claim 1 of us 10058546; Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the f508del mutation or heterozygous for the f508del mutation and a second mutation that is responsive to tezacaftor/ivacaftor; Treatment of cystic fibrosis in patients ages 12 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; Treatment of cystic fibrosis in patients ages 6 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; Treatment of cystic fibrosis in patients age 6 and older, who have two copies of the f508del mutation or at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; Treatment of cystic fibrosis in patients age 12 and older, who have two copies of the f508del mutation or at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; Treatment of cystic fibrosis in patients aged 6 years and older, who are homozygous for the f508del mutation or have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with an effective amount of tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older, who are homozygous for the f508del mutation or have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with an effective amount of tezacaftor and ivacaftor

Dosage: TABLET;ORAL

Drugs and Companies using ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR ingredient

NCE-1 date: October, 2023

Market Authorisation Date: 21 October, 2019

Treatment: Treatment of a moderate to mild clinical phenotype of cf in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatment of a moderate to mild clinical phenotype of cf in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elx, tez, and iva; Treatment of a moderate to mild clinical phenotype of cf in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elx, tez, and iva; Treatment of cystic fibrosis in patients aged 12 years and older who have one f508del mutation and one r117h mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older who have a r117h mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have a r117h mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatment of cf in patients aged 12 years and older who have at least one f508del mutation in the cftr gene using a solid composition comprising elexacaftor, tezacaftor, amorphous ivacaftor, and less than about 30% crystalline ivacaftor; Treatment of cf in patients 12 years and older who have at least one f508del mutation or a mutation in the cftr gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva; Treatment of cf in patients 6 years and older who have at least one f508del mutation or a mutation in the cftr gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with an effective amount of a pharmaceutical composition comprising elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene with an effective amount of a pharmaceutical composition comprising elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with a composition according to claim 1 of us 10081621; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with a composition according to claim 1 of us 10081621; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with a composition according to claim 1 of us 10081621; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with a composition comprising elexacaftor, tezacaftor, and ivacaftor; And another composition comprising ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene with a composition comprising elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data with a composition according to at least one of claims 1-9 of us11179367; Treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data by administering daily elx (200 mg or 100 mg); Tez; And iva; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with an effective amount of elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva; Treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data with a compound of claim 1 or composition of claim 29 of us11426407

Dosage: TABLET;ORAL