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Last Updated: October 18, 2019

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Claims for Patent: 10,058,546

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Summary for Patent: 10,058,546
Title:Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof
Abstract: A pharmaceutical composition comprising Compound 1, (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarbox- amide, and at least one excipient selected from: a filler, a disintegrant, a surfactant, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering the pharmaceutical composition of Compound 1 are also disclosed.
Inventor(s): Alargova; Rossitza Gueorguieva (Brighton, MA), Dunbar; Craig Antony (Needham, MA), Kadiyala; Irina Nikolaevna (Newton, MA)
Assignee: Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:15/342,999
Patent Claims: 1. A method for treating cystic fibrosis in a patient, comprising coadministering: a) a pharmaceutical composition comprising 5 to 250 mg of (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl- )-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecar- boxamide (Compound 1) and a pharmaceutically acceptable carrier, wherein Compound 1 is in a spray dried dispersion; and b) another pharmaceutical composition comprising 100 to 300 mg N-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1H-quinoline-3-carboxamide (Compound 2) and a pharmaceutically acceptable carrier; wherein the patient has a .DELTA.F508 or G551D cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation and a second CFTR gene mutation selected from R117H, A455E, 2789+5G.fwdarw.A, and 3849+10kbC.fwdarw.T; wherein the pharmaceutical composition of step (a) is administered concurrently with the pharmaceutical composition of step (b).

2. The method of claim 1, wherein Compound 1 is substantially amorphous, wherein less than 15% of Compound 1 is in crystalline form.

3. The method of claim 2, wherein less than 10% of Compound 1 is in crystalline form.

4. The method of claim 3, wherein less than 5% of Compound 1 is in crystalline form.

5. The method of claim 4, wherein less than 1% of Compound 1 is in crystalline form.

6. The method of claim 1, wherein Compound 1 is present in an amount of about 100 mg.

7. The method of claim 1, wherein the pharmaceutical composition of step (a) and the pharmaceutical composition of step (b) are administered once a day.

8. The method of claim 1, wherein 150 mg of Compound 2 is administered.

9. The method of claim 1, wherein the method comprises administering an additional therapeutic agent.

10. The method of claim 9, wherein the additional therapeutic agent is a mucolytic agent, bronchodilator, an antibiotic, an anti-infective agent, an anti-inflammatory agent, a CFTR modulator other than Compound 2, or a nutritional agent.

11. The method of claim 9, wherein the additional therapeutic agent is a CFTR modulator other than Compound 2.

12. The method of claim 1, wherein the second CFTR gene mutation is A455E.

13. The method of claim 1, wherein the second CFTR gene mutation is 2789+5G.fwdarw.A.

14. The method of claim 1, wherein the second CFTR gene mutation is 3849+10kbC.fwdarw.T.

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