GlaxoSmithKline’s new COPD drug accepted for US review

GlaxoSmithKline and Theravance have announced that their investigational long-acting muscarinic antagonist/long-acting beta 2 agonist combination medicine UMEC/VI has been accepted for US regulatory review.

The chronic obstructive pulmonary disease (COPD) drug has had its new drug application submission ratified by the US Food and Drug Administration, which suggests the application is complete enough for a substantive review to take place.

It comes after the European Medicines Agency validated the new compound's marketing authorisation application and will pave the way for further regulatory submissions in the coming months.

GlaxoSmithKline has settled on a proposed brand name of Anoro for the therapy, which combines the investigational bronchodilator molecules umeclidinium bromide (UMEC) and vilanterol (VI) into a single inhaler-based treatment.

It is one of a number of potentially promising late-stage assets in the company's respiratory development portfolio.

Earlier this month, GlaxoSmithKline announced that it has also submitted its new metastatic melanoma therapy trametinib for approval by the European Medicines Agency.