GlaxoSmithKline and Innoviva seek to broaden Trelegy Ellipta indication
GlaxoSmithKline, along with its partner Innoviva, announced the filing of a supplemental New Drug Application (sNDA) with the US Food and Drug Administration on Thursday, for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol).
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The FTSE 100 drugmaker said the application was for an expanded indication, for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease.
It said approval of the sNDA would mean FF/UMEC/VI could be used by physicians to treat a wider population of patients with COPD, who are at risk of an exacerbation and require triple therapy.
GSK explained that FF/UMEC/VI is the first treatment to provide a combination of three molecules in a single inhaler, which only needs to be taken once a day.
It contains an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta2-adrenergic agonist, delivered once daily in its Ellipta dry powder inhaler, which is used across the entire new portfolio of inhaled COPD medicines.
“Data from GSK's landmark IMPACT study provide important information on the efficacy and safety of these molecules combined in a single inhaler and the benefit they can bring to appropriate patients when delivered as a triple combination therapy,” said Patrick Vallance, GlaxoSmithKline president of research and development.
“We have moved swiftly to file these data with the FDA.”
In the IMPACT study, FF/UMEC/VI showed superiority to the dual combination therapies on multiple endpoints, including exacerbation rates, lung function and health related quality of life.
GSK said that built on “substantial evidence” from across multiple clinical programmes that demonstrated the benefit of the molecules in FF/UMEC/VI both alone and in combination, for the treatment of COPD.
FF/UMEC/VI was approved for use in the US on 18 September for the long-term, once-daily, maintenance treatment of COPD patients who are receiving Breo (FF/VI) and require additional bronchodilation, or who are receiving Breo and Incruse (UMEC).
If approved, the sNDA would broaden that indication.
“Trelegy Ellipta adds to the portfolio of Ellipta inhaled therapies, which has been developed because patients have different treatment needs,” said Innoviva CEO Michael Aguiar.
“We believe the IMPACT data will provide clarity to physicians on how to treat patients based on their symptoms and risk profile and that Trelegy Ellipta will play an important role in treating patients who remain symptomatic and at risk of an exacerbation despite current therapy.”