FDA accepts new drug application for the LAMA/LABA combination
GlaxoSmithKline's (GSK) investigational respiratory treatment Anoro is under review by the FDA after the US regulator accepted its new drug application.
GSK and its development partner Theravance submitted the medicine for approval to treat patients with chronic obstructive pulmonary disease (COPD), and the FDA is expected to make a decision by December 18, 2013.
Anoro is one of several COPD products in development that combine a long-acting muscarinic antagonist (LAMA) with a long-acting beta agonist (LABA), both of which are already used separately to treat respiratory conditions.
In the case of Anoro, the two molecules combined are the LAMA umeclidinium bromide (UMEC), also known as GSK573719, and the LABA vilanterol (VI), with the medicine intended to be administered using GSK's Ellipta inhaler.
The US submission follows Anoro's filing with the European Medicines Agency (EMA) in January 2013, and gives GSK a march over its rivals.
Boehringer's LAMA/LABA combination olodaterol/tiotropium has yet to be submitted for approval in either region, while Novartis' QVA149 (glycopyrronium bromide and indacaterol maleate) was filed for approval in Europe and Japan in October, but is not expected to be submited for FDA approval until 2014.
FDA priority review for ViiV Healthcare's HIV drug
GSK received separate good news in the past week when the FDA granted a priority review to the investigational HIV treatment dolutegravir.
The drug is being developed by ViiV Healthcare – a joint venture between GSK and Pfizer – and will now received an accelerated approval process, with the FDA expected to make a decision on dolutegravir's approval by August 17, 2013.
The FDA will review data from a phase III programme that demonstrated the integrase inhibitor was more effective than Gilead Sciences/Bristol-Myers Squibb's big-selling Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate), a fixed-dose triple therapy for HIV.