FDA approval GSK’s triple therapy inhaler for COPD
FDA has recently approved GSK’s triple therapy inhaler, the news follows on shortly from an EMA CHMP positive opinion and the FDA advisory panel’s recent nod for its shingles vaccine, Shingrix.
The news was highly welcomed, especially in the chronic obstructive pulmonary disease (COPD) area, as the current major seller in the area, Advair, faces generic threats. GSK hopes their treatment, Trelegy Ellipta, will fill the gap left by the falling sales of Advair,which still managed to generate $4.71 billion in revenue for the company, representing half of its sales in the respiratory area.
Analysts expect Trelegy Ellipta to garner between $1 billion and $1.5 billion, as the company estimates that roughly a quarter of all COPD patients are currently using three drugs to manage their condition. GSK hopes that the convenience, and the carry-over from brand awareness of Advair, will help the product strengthen sales in the US.
Eric Dube, SVP and Head of GSK Global Respiratory Franchise, commented: “COPD is a progressive disease that can worsen over time, and represents a significant burden to patients and healthcare systems. The approval of Trelegy Ellipta, and the addition of a once-daily single inhaler triple therapy to our portfolio of respiratory medicines, is an important milestone for GSK that builds on our long heritage in this area.”
After the EMA’s CHMP nod, the product looks likely to be approved in Europe before the end of the year.GSK also announced that it plans to make the product available in the US ‘shortly’, thereby potentially allowing them to consolidate its presence in the market before the inevitable generic versions emerging from Mylan, Sandoz and Hikma Pharmaceuticals.
Trelegy Ellipta is part of three major products that GSK expects to drive growth, alongside its shingles vaccine and its double-dose HIV maintenance therapy.