GlaxoSmithKline (GSK) announced that the first asthma patient has commenced treatment with Relovair (fluticasone furoate/vilanterol trifenatate) in an asthma exacerbation study, marking the start of the phase-III clinical development programme with this once daily therapy, for this serious and chronic disease.
The asthma programme for Relovair (previously referred to as ‘Horizon’) will assess the potential benefit of the combination of inhaled corticosteroid, fluticasone furoate, and long-acting beta agonist, vilanterol trifenatate (642444) versus the component products and existing treatments for asthma.
The programme will consist of a range of eight studies to determine the efficacy and safety of Relovair in asthma patients who remained uncontrolled on current treatment. The initiation of the exacerbation study complements a 12-month safety study that is already underway in support of the COPD programme. An additional six efficacy studies, including three comparator studies, are scheduled to start within the next quarter.
GSK is in ongoing discussions with the US FDA regarding the US component of the global asthma programme following the recent US FDA Advisory Committee meeting and the US FDA’s proposed changes to the use of LABA-containing products in asthma.
Relovair is being developed under the long-acting beta2 agonist (LABA) collaboration entered into in November 2002 with Theravance, Inc. a biopharmaceutical company with a pipeline of internally discovered product candidates.