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GSK to sell stake in Innoviva for $392m pharmaceutical-technology
May 24, 2021
GlaxoSmithKline (GSK) has entered a definitive agreement to sell its entire equity stake in royalty management company Innoviva at $12.25 for each share, taking the deal proceeds to a total of nearly $392m.
CHMP opinions: EMA refuses asthma label expansion for GSK’s COPD drug Trelegy Ellipta pharmaceutical-technology
March 02, 2021
The European Union’s healthcare regulator the European Medicines Agency (EMA) has decided against a label expansion for GlaxoSmithKline (GSK)’s drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include asthma.
US expands scope of Trelegy Ellipta to include asthma pharmatimes
September 24, 2020
GlaxoSmithKline and Innoviva's Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI) has bagged a new indication in the US with approval for use to treat asthma in patients aged 18 years.
GSK gets US FDA approval for Trelegy Ellipta to treat asthma, COPD expresspharma
September 18, 2020
Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD.
Trelegy Ellipta filing accepted by EMA for asthma pharmatimes
March 06, 2020
The European Medicines Agency (EMA) has accepted GlaxoSmithKline’s regulatory submission seeking an additional indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the treatment of asthma.
EU expands label of GSK/Innoviva’s COPD inhaler pharmatimes
November 14, 2018
GSK noted that while bronchodilation is recognised as the foundation of COPD therapy, “many patients may continue to struggle with symptoms and exacerbations over time”.
Trelegy Ellipta Gains Expanded COPD Indication in Europe americanpharmaceuticalreview
November 10, 2018
“We are pleased that the European Commission has approved the expanded use of Trelegy Ellipta as this will enable even more COPD patients to benefit from this important medicine,” Dr. Hal Barron, Chief Scientific Officer and President, R&D, GSK, said.
GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy El worldpharmanews
November 24, 2017
Approval of this sNDA means 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, Innoviva announce US nod for Trelegy Ellipta pharmatimes
September 20, 2017
GlaxoSmithKline and Innoviva have bagged a green light in the US for the novel triple therapy inhaler Trelegy Ellipta, opening the door to a new treatment option for patients with Chronic Obstructive Pulmonary Disorder (COPD).