US FDA panel in favour of GSK, Theravance COPD drug
The US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted in favour of GSK and Theravance Inc’s chronic obstructive pulmonary disease (COPD) drug.
The panel voted 11-2 to approve Anoro (the proposed brand name for UMEC/VI), which is a combination of two investigational bronchodilator molecules – GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA™ inhaler.
The panel believed that the efficacy and safety data provided substantial evidence to support approval of Anoro for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
“Today’s recommendation is good news and a reflection of our commitment to giving an alternative treatment option for patients living with COPD – a disease that affects millions of Americans. If approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the US, marking another significant milestone for GSK’s portfolio of medicines to treat respiratory disease. We will continue to work with the FDA as they complete their review.”
Patrick Vallance, GSK’s President of Pharmaceuticals R&D.
The US regulatory body is not required to follow its advisory panel’s advice on recommendation, but typically does so. The Prescription Drug User Fee Act (PDUFA) goal date for UMEC/VI is set for the 18th December 2013.
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