FDA approves expanded use for GSK’s COPD triple therapy

The FDA has approved an expanded label for GlaxoSmithKline’s new Trelegy Ellipta inhaler, allowing it to be used in a broader population of patients with chronic obstructive pulmonary disease (COPD).

GSK is aiming to revive its respiratory drugs franchise with drugs such as Trelegy, a triple therapy that aims to provide a more convenient single daily dose for patients with advanced disease, needing to take several drugs to keep symptoms at bay.

The UK pharma’s ageing Advair inhaler, still a mainstay of GSK’s respiratory portfolio, is threatened by generic competition and the firm needs new drugs to replace its blockbuster level sales.

Advair, known as Seretide elsewhere, is off-patent and only the FDA’s tough approach to copies of therapies combining an inhaler and a drug is keeping competitors at bay.

The new US indication for Trelegy is for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Its new use is based on an analysis of the phase 3 IMPACT study, which showed Trelegy was better than GSK’s already approved combinations Relvar/Breo Ellipta and Anoro Ellipta.

Trelegy is also indicated to reduce exacerbations of COPD in patients with a history of these symptoms, although it is not indicated for relief of acute bronchospasm or for the treatment of asthma.

Trelegy combines fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler used across the company’s portfolio of inhaled COPD drugs.

It was first approved in September last year for the long-term, once-daily, maintenance treatment of patients with COPD, including chronic bronchitis and/or emphysema, who need further help with exacerbations, or who are already receiving the three drugs in two different inhalers.

European regulators are also reviewing the dossier for the expanded label, which was filed in February.

GSK’s chief scientific officer, Hal Barron, said GSK will look for further uses for Trelegy. "We will continue to analyse the data from the IMPACT trial and our ongoing Trelegy Ellipta studies to demonstrate further the value of this important medicine to patients," he said.

Register as Visitor to CPhI China 2018!