US 11,673,967 B2
Stabilized formulations containing anti-PCSK9 antibodies
Scott M. Walsh, Sewickley, PA (US); and Daniel B. Dix, Lagrangeville, NY (US)
Assigned to REGENERON PHARMACEUTICALS, INC., Tarrytown, NY (US)
Filed by Regeneron Pharmaceuticals, Inc., Tarrytown, NY (US)
Filed on Jul. 16, 2020, as Appl. No. 16/930,595.
Application 16/930,595 is a continuation of application No. 16/384,298, filed on Apr. 15, 2019, granted, now 10,752,701.
Application 16/384,298 is a continuation of application No. 15/603,732, filed on May 24, 2017, granted, now 10,472,425, issued on Nov. 12, 2019.
Application 15/603,732 is a continuation of application No. 14/918,109, filed on Oct. 20, 2015, abandoned.
Application 14/918,109 is a continuation of application No. 14/319,730, filed on Jun. 30, 2014, granted, now 9,193,801, issued on Nov. 24, 2015.
Application 14/319,730 is a continuation of application No. 13/559,862, filed on Jul. 27, 2012, granted, now 8,795,669, issued on Aug. 5, 2014.
Claims priority of provisional application 61/512,666, filed on Jul. 28, 2011.
Prior Publication US 2021/0054100 A1, Feb. 25, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. C07K 16/40 (2006.01); A61K 39/395 (2006.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); A61M 5/315 (2006.01); A61M 5/32 (2006.01)
CPC C07K 16/40 (2013.01) [A61K 39/3955 (2013.01); A61K 39/39591 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61M 5/31513 (2013.01); A61M 5/3202 (2013.01); C07K 2317/565 (2013.01); C07K 2317/94 (2013.01)] 3 Claims
 
1. A pre-filled pen delivery device comprising a liquid pharmaceutical formulation, wherein the liquid pharmaceutical formulation consists of:
(a) 50±7.5 mg/mL to 250±37.5 mg/mL of an antibody or antigen-binding fragment thereof that specifically binds human proprotein convertase subtilisin kexin-9 (PCSK9), wherein the antibody or antigen-binding fragment comprises a heavy chain variable domain (HCVD) comprising SEQ ID NO:1, and a light chain variable domain (LCVD) comprising SEQ ID NO:5;
(b) 5±0.75 mM to 10±1.5 mM histidine, pH 6.0±0.3;
(c) 0.01±0.0015% w/v polysorbate 20; and
(d) 10±1.5% w/v sucrose.