GSK submits landmark IMPACT data to support expanded label for Trelegy Ellipta
Source - SMW
GlaxoSmithKline and Innoviva announced the submission of the landmark InforMing the PAthway of COPD Treatment (IMPACT) data to the European Medicines Agency to support an expanded label for Trelegy Ellipta in Europe.
Approval of the submission would mean FF/UMEC/VI could be used by physicians to treat a wider population of patients with the condition who are at risk of an exacerbation and require triple therapy.
Dave Allen, Head, Respiratory Therapy Area, R&D, GSK said: 'This filing is primarily based on the IMPACT study, which clarifies the type of patient most likely to benefit from once-daily single inhaler triple therapy, and adds to the evidence supporting the clinical profile of Trelegy Ellipta. The submission reflects our confidence in this medicine, which we believe has the potential to be an effective treatment option for appropriate patients with COPD who require triple therapy for symptom relief and exacerbation reduction.'
At 9:26am: (LON:GSK) GlaxoSmithKline PLC share price was -1.8p at 1289.2p