Company Product Description Indication Status
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

Notes

For more information about individual companies and/or products, see Cortellis.

No Comments