European green light for GSK’s Anoro

GlaxoSmithKline’s new treatment for COPD Anoro has received a positive opinion from the European regulator’s CHMP committee.

GSK has twinned its long-acting muscarinic antagonist (LAMA), umeclidinium with long-acting beta 2 adrenoreceptor agonist (LABA) vilanterol, to create the first ever once daily COPD treatment.

This combination has also received approval in the US, and has been tipped to be a blockbuster for GSK and its partner Theravance. Analysts predict peak sales in excess of £2 billion, and the drug combination gives GSK a follow-up product for its existing COPD blockbuster, Seretide/Advair.

Final marketing approval is expected from the European Commission in the second quarter of 2014.

The phase III pivotal programme for UMEC/VI included seven clinical studies with almost 6,000 patients with COPD.

Not for asthma patients

There are some clear drawbacks for the new COPD treatment because of some significant contraindications.

Umeclidinium should not be used in patients with asthma since it has not been studied in this patient population. Administration of umeclidinium may produce paradoxical bronchospasm that may be life-threatening, and should not be used to treat acute episodes of bronchospasm.

The drug should also be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias, as muscarinic receptor antagonists carry the risk of arrhythmias e.g. atrial fibrillation and tachycardia.

Also in GSK’s respiratory pipeline is VI monotherapy and MABA (GSK961081), developed with Theravance, as well as GSK’s fluticasone furoate monotherapy and anti-IL5 MAb (mepolizumab).

Links

GSK, Theravance respiratory drug approved for use in Europe

FDA approves GSK’s COPD product

 

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