GlaxoSmithKline, Theravance's Relvar Ellipta approved in Japan for asthma

GlaxoSmithKline and Theravance announced Friday that the Japanese Ministry of Health, Labour and Welfare (MHLW) authorised the sale of Relvar Ellipta (fluticasone furoate/vilanterol) as a treatment for bronchial asthma. "This first approval of Relvar Ellipta in asthma represents yet another significant milestone in the respiratory partnership between Theravance and [GlaxoSmithKline]," remarked Theravance CEO Rick Winningham.

The once-daily inhaled therapy was cleared in the US in May under the trade name Breo Ellipta for the treatment of chronic obstructive pulmonary disease (COPD), while the European Medicines Agency's Committee for Medicinal Products for Human Use recently issued a positive opinion recommending approval in both asthma and COPD. However, in July, GlaxoSmithKline and Theravance withdrew their Japanese application for the treatment in the COPD indication.

According to the companies, the Japanese regulator cleared two doses of Relvar for use in patients with asthma in cases where concurrent use of an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA) is required. The therapy is administered using the Ellipta dry powder inhaler.

Also on Friday, the MHLW approved Novartis' Ultibro Breezhaler, a combination of the LABA Onbrez (indacaterol) and the long-acting muscarinic antagonist Seebri (glycopyrronium bromide), for the relief of symptoms due to airway obstruction in patients with COPD. The agency also cleared Skyepharma's Flutiform, which will be sold in Japan by Kyorin Pharmaceutical, for the treatment of adults with bronchial asthma. The product combines the LABA formoterol and the ICS fluticasone.

For related analysis of Relvar and other LABA/ICS combinations, see Physician Views Poll Results – European pulmonologists appear less receptive to once-daily LABA/ICS therapies than US counterparts for COPD and ViewPoints: Nearly a quarter of European patients struggle to comply with twice-daily dosing when treated with LABA/ICS combination therapies.

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