GSK, Bayer Lead Pipeline News
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from GlaxoSmithKline and Bayer.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, November 1, 2017 to Tuesday, November 7, 2017.
FDA Grants Breakthrough Therapy Designation for GSK’s Myeloma ADC
GlaxoSmithKline has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for GSK2857916, an anti B-cell maturation agent monoclonal antibody-drug conjugate, for treating patients with multiple myeloma.
Specifically, the designation is for treating patients who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent.
In October 2017, the European Medicines Agency (EMA) granted Prime designation to GSK2857916 for treating relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Prime designation is offered by the EMA to enhance support for the development of medicines that target an unmet medical need.
Bayer Submits Application to EMA for Combination Use for Anticoagulant Xarelto
Bayer has submitted a marketing authorization application to the European Medicines Agency (EMA) for approval of the vascular dose of its Factor Xa inhibitor, Xarelto (rivaroxaban), in combination with aspirin for treating patients with coronary artery disease or peripheral artery disease.
Xarelto is approved for seven indications: (1) the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and one or more risk factors; (2) treating pulmonary embolism (PE) in adults; (3) treating deep vein thrombosis (DVT) in adults; (4) preventing recurrent PE and DVT in adults; (5) preventing venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery; (6) preventing VTE in adult patients undergoing elective knee replacement surgery; and (7) preventing atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an acute coronary syndrome in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine.
Rivaroxaban was discovered by Bayer and is being jointly developed with Janssen Research & Development, part of the pharmaceutical companies of Johnson & Johnson. Xarelto is marketed outside the US by Bayer and in the US by Janssen Pharmaceuticals.
A filing in the US is expected by the end of 2017.