FDA Approves Trelegy Ellipta for Chronic Obstructive Pulmonary Disease from GSK

  • 2017-09-28

Recently, GSK and Innovina Inc. (INVA) have announced that the Trelegy Ellipta for chronic obstructive pulmonary disease (COPD) has been approved by FDA.

COPD is a serious chronic disease that worsens over time. Today there are about 384 million COPD patients around the world, which afflicts patients and imposes a heavy burden on society. Trelegy Ellipta is an inhaled triple-drug therapy. Its principle is that the three drugs marketed for many years, i.e. Fluticasone furoate (FF), umeclidinium (UMEC) and vilanterol (VI), are loaded into the Elipta (an inhaler drug device) as per the dose of FF/UMEC/VI 100/62.5/25ug. Patients with COPD shall undergo a daily inhalation therapy, which requires a long time. However, Trelegy Ellipta indications do not include acute bronchospasm and asthma.

Mike Aguiar, the CEO of Innoviva, said “the approval of Trelegy Ellipta will be of great convenience to patients currently receiving treatment with the Breo Ellipta (dual therapy with fluticasone and vilanterol) and the bronchodilator Ellipta.”

 Trelegy Ellipta has been approved by the FDA and it is expected to go public soon in the US. Trelegy Ellipta is under evaluation of drug regulatory authorities in the European Union, Australia and Canada in addition to the US. Trelegy Ellipta is first once-daily single inhaler triple therapy approved by the FDA, and the drug was recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on September 15. Analysts expect the sales peak of Trelegy Ellipta achieves 1~2 billion USD.