Once-a-day Triple Combo Inhaler for COPD Patients Favored for Approval in EU

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A triple combination inhaler for people with moderate to severe adult chronic obstructive pulmonary disease (COPD) was recommended for approval and use across the European Union this week by CHMP, the scientific arm of the European Medicines Agency’s (EMA).

CHMP’s official name is the Committee for Medicinal Products for Human Use.

The triple combination inhaler, whose active ingredients are fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), was developed by GlaxoSmithKline (GSK) and Innoviva and will be available under the name Trelegy Ellipta if approved by the European Commission. EC decisions typically adhere to CHMP and EMA recommendations.

The once-daily maintenance treatment is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), delivered once a day using GSK’s Ellipta dry powder inhaler. FF/UMEC/VI are expected to be used at a strength of 100/62.5/25 mcg.

It is intended for adults wth moderate to severe COPD who have had a poor response to the dual Symbicort/Turbohaler (budesonide/formoterol) bronchodilator, a combination of a corticosteroid and a LABA.

CHMP’s recommendation was based on results of the Phase 3 FULFIL clinical trial (NCT02345161), which showed that 911 COPD patients using the triple combo once-daily inhaler significantly improved lung function and health-related quality of life compared to 899 patients using the Symbicort/Turbohaler inhaler twice a day.

“We believe once-daily single inhaler triple therapy, if approved, would provide an important option for appropriate patients with COPD who are receiving ICS/LABA and require additional bronchodilation, avoiding the need for multiple inhalers,” Patrick Vallance, GSK’s president, said in a press release.

The COPD triple combo is also under assessment by the U.S. Food and Drug Administration (FDA), where a decision is possible soon, and by regulatory agencies in Australia and Canada.

In the EU, CHMP is responsible for giving an initial scientific assessment of a therapy’s suitability — its safety and efficacy — for marketing authorization based on clinical trial data. The EMA typically accepts a CHMP decision, and submits it to the European Commission, where a final approval decision is made. An EC decision is expected in later this year.

“This positive opinion will lead to a significant therapeutic convenience for those appropriate patients already on ICS/LABA treatment that require additional bronchodilation” said Mike Aguiar, CEO of Innoviva. “Trelegy is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”

Side effects for the triple combo inhaler were seen in clinical studies to be similar to the Symbicort/Turbohaler inhaler. The most frequently reported adverse reactions were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%). Other common reactions included pneumonia, pharyngitis, rhinitis, influenza, cough, arthralgia (joint pain), and back pain.

Other respiratory products jointly developed by GSK and Innoviva  include Relvar Ellipta for COPD and asthma, Breo Ellipta for COPD and asthma, and Anoro Ellipta for COPD.