GSK And Theravance : Anoro Ellipta Gets Approval In Japan For Treatment Of COPD

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) and Theravance Inc. (THRX) announced that the Japanese Ministry of Health, Labour and Welfare or MHLW has approved Anoro Ellipta (umeclidinium/vilanterol) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (chronic bronchitis, pulmonary emphysema) (in the case where concurrent use of long-acting inhaled muscarinic antagonist and long-acting inhaled beta2 agonist is required).

Anoro is a once-daily combination treatment comprised of two bronchodilators, umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single inhaler, the Ellipta. The approved dose in Japan is UMEC/VI 62.5/25mcg delivered once daily.

As per the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $10 million to GSK following MHLW approval of UMEC/VI in Japan.Following this approval, it is expected that launch will take place in Japan in the third-quarter of 2014.

COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. It is characterised by obstruction to airflow that interferes with normal breathing.

The company said that Anoro Ellipta is not intended to treat bronchial asthma, and therefore should not be used as such. If Anoro Ellipta is used in patients with COPD complicated with bronchial asthma, care should be taken to ensure that bronchial asthma is sufficiently managed.

Anoro Ellipta is not intended to treat an acute exacerbation of COPD. In patients who do not respond to Anoro Ellipta even when it is given in accordance with the recommended dosage and administration, Anoro Ellipta should be discontinued.

Anoro Ellipta can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs Anoro Ellipta should be discontinued immediately and alternative therapy should be instituted.