|Aerie Pharmaceuticals Inc., of Durham, N.C.||Roclanda (netarsudil and latanoprost ophthalmic solution)||Combination of Rho kinase inhibitor with prostaglandin analogue||Elevated intraocular pressure in open-angle glaucoma or ocular hypertension||EMA accepted for review MAA; opinion from agency’s Committee for Medicinal Products for Human Use expected in late 2020|
|Amarin Corp. plc, of Dublin||Vascepa (icosapent ethyl)||Eicosapentaenoic acid||Cardiovascular disease||Approved by Health Canada for use in reducing risk of cardiovascular events in statin-treated patients with elevated triglycerides who are at high risk of CV events due to established CV disease, or diabetes, and have at least 1 other CV risk factor|
|Innate Pharma SA, of Marseille, France||Lumoxiti (moxetumomab pasudotox-tdfk)||CD22-directed immunotoxin||Relapsed or refractory hairy cell leukemia||EMA accepted MAA seeking approval for use in adults who have received at least 2 prior systemic therapies, including treatment with a purine nucleoside analogue|
|Mesoblast Ltd., of Melbourne, Australia||Remestemcel-L||Therapy comprising culture-expanded mesenchymal stem cells derived from bone marrow of an unrelated donor||Steroid-refractory acute graft-vs.-host disease||FDA confirmed receipt of rolling BLA seeking approval for use in children; final module of BLA will be filed in January, and company will request expedited FDA review|
|Molecular Partners AG, of Zurich-Schlieren, Switzerland||MP-0250||Trispecific multi-DARPin neutralizing VEGF-A and HGF||Multiple myeloma||FDA granted orphan designation|
For more information about individual companies and/or products, see Cortellis.