GSK's Trelegy On Track To Be First Triple Inhaled Regimen For Asthma
The company filed an sNDA with the US FDA for the triple combination, hoping to expand its current COPD indication to also include asthma.
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Trelegy, already approved for COPD, will be targeted to the roughly one-third of asthmatics not controlled on maintenance therapy.
The Swiss company's asthma triplet is now approved in Europe and Japan but Enerzair is well behind GSK's rival LABA/LAMA/ICS in the US where Novartis's product has not even been submitted yet.
Novartis is among a number of companies that this week moved closer to marketing new products across the EU. D&A Pharma has again failed to convince the European Medicines Agency that its alcohol dependence treatment should be approved.