GSK, Theravance Announce Relvar Ellipta Approval In Japan For Asthma Treatment

(RTTNews) - GlaxoSmithKline plc(GSK, GSK.L), and Theravance, Inc.(THRX), Friday said that Relvar Ellipta for the treatment of bronchial asthma got approval from the Japanese Ministry of Health, Labour and Welfare. The company said Relvar Ellipta is not indicated for the treatment of chronic obstructive pulmonary disease in Japan.

Relvar is a combination of the inhaled corticosteroid, fluticasone furoate 'FF', and the long-acting beta2 agonist or LABA, vilanterol 'VI'. The ministry has approved two doses of FF/VI - 100/25 mcg and 200/25 mcg. Both strengths will be administered once everyday using a new dry powder inhaler, Ellipta. FF/VI is not approved or licensed anywhere outside of Japan for the treatment of asthma, Theravance said.

"This first approval of Relvar Ellipta in asthma represents yet another significant milestone in the respiratory partnership between Theravance and GSK," said Rick Winningham, Chief Executive Officer of Theravance.

Under the agreement, Theravance has to make a milestone payment of $10 million to GSK on approval of Relvar Ellipta in Japan.