US 12,168,021 B2
Methods for treating pulmonary non-tuberculous mycobacterial infections
Gina Eagle, Morristown, NJ (US); and Renu Gupta, Moorestown, NJ (US)
Assigned to Insmed Incorporated, Bridgewater, NJ (US)
Filed by INSMED INCORPORATED, Bridgewater, NJ (US)
Filed on Jun. 21, 2022, as Appl. No. 17/845,688.
Application 17/845,688 is a continuation of application No. 17/031,744, filed on Sep. 24, 2020, granted, now 11,395,830.
Application 17/031,744 is a continuation of application No. 16/778,506, filed on Jan. 31, 2020, granted, now 10,828,314, issued on Nov. 10, 2020.
Application 16/778,506 is a continuation of application No. 16/515,303, filed on Jul. 18, 2019, granted, now 10,588,918, issued on Mar. 17, 2020.
Application 16/515,303 is a continuation of application No. 16/250,476, filed on Jan. 17, 2019, granted, now 10,398,719, issued on Sep. 3, 2019.
Application 16/250,476 is a continuation of application No. 15/311,488, granted, now 10,238,675, issued on Mar. 26, 2019, previously published as PCT/US2015/031079, filed on May 15, 2015.
Claims priority of provisional application 62/056,296, filed on Sep. 26, 2014.
Claims priority of provisional application 62/048,068, filed on Sep. 9, 2014.
Claims priority of provisional application 62/042,126, filed on Aug. 26, 2014.
Claims priority of provisional application 61/993,439, filed on May 15, 2014.
Prior Publication US 2022/0395524 A1, Dec. 15, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/7036 (2006.01); A61K 9/00 (2006.01); A61K 9/127 (2006.01); A61K 31/133 (2006.01); A61K 31/407 (2006.01); A61K 31/4375 (2006.01); A61K 31/4409 (2006.01); A61K 31/4709 (2006.01); A61K 31/496 (2006.01); A61K 31/5383 (2006.01); A61K 31/546 (2006.01); A61K 31/65 (2006.01); A61K 31/7048 (2006.01); A61K 31/7052 (2006.01); A61K 45/06 (2006.01); A61P 31/04 (2006.01)
CPC A61K 31/7036 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0053 (2013.01); A61K 9/0078 (2013.01); A61K 9/127 (2013.01); A61K 31/133 (2013.01); A61K 31/407 (2013.01); A61K 31/4375 (2013.01); A61K 31/4409 (2013.01); A61K 31/4709 (2013.01); A61K 31/496 (2013.01); A61K 31/5383 (2013.01); A61K 31/546 (2013.01); A61K 31/65 (2013.01); A61K 31/7048 (2013.01); A61K 31/7052 (2013.01); A61K 45/06 (2013.01); A61P 31/04 (2018.01)] 27 Claims
 
1. A method for treating a non-cystic fibrosis (CF) Mycobacterium avium complex (MAC) lung infection in a patient in need thereof, comprising:
administering to the lungs of the patient a pharmaceutical composition comprising amikacin, or a pharmaceutically acceptable salt thereof, encapsulated in a plurality of liposomes, wherein the lipid component of the plurality of liposomes consists of an electrically neutral phospholipid and cholesterol,
wherein administering to the lungs of the patient comprises aerosolizing the pharmaceutical composition to provide an aerosolized pharmaceutical composition comprising a mixture of free amikacin, or a pharmaceutically acceptable salt thereof, and liposomal complexed amikacin, or a pharmaceutically acceptable salt thereof, and administering the aerosolized pharmaceutical composition via a nebulizer to the lungs of the patient once daily in a single dosing session, for an administration period of at least 84 days,
administering to the patient during the administration period one or more additional therapeutic agents selected from the group consisting of a macrolide antibiotic, a rifamycin, and ethambutol, and
wherein the treating comprises achieving a negative MAC sputum culture in the patient during the administration period or subsequent to the administration period.