Trelegy Approval Boosts GSK's US Respiratory Business But Pressure Remains
With the FDA approval of Trelegy Ellipta, GlaxoSmithKline will enjoy first-to-market status with a LABA/LAMA/ICS triple combination therapy to treat COPD in the US. However, it faces the challenge of convincing payers.
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Trelegy, already approved for COPD, will be targeted to the roughly one-third of asthmatics not controlled on maintenance therapy.
Issued with a complete response letter from the FDA, the company says it will now submit newer data showing the combination's effects on exacerbations.
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