GSK gets FDA approval for key triple therapy inhaler

pharmafile | September 20, 2017 | News story | Research and Development, Sales and Marketing GSK, Trelegy Ellipta, biotech, drugs, pharma, pharmaceutical 

The good news keeps on rolling in for GSK, with the FDA approval for its 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 is badly needed, especially in the chronic obstructive pulmonary disease (COPD) area, as its current major seller in the area, Advair, faces generic threats from all angles. GSK hopes that Trelegy Ellipta, as the product is known, will be able to fill the gap left by 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 for the company, as the company itself estimates that approximately a quarter of all COPD patients are currently using three drugs to manage their condition. GSK is hoping the convenience, and the carry-over from brand awareness of Advair, will help the product cement sales in the US.

Eric Dube, SVP and Head of GSK Global Respiratory Franchise, said, “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.”

As mentioned, after the EMA’s CHMP nod, the product looks likely to be approved in Europe before the end of the year and GSK announced that it plans to make the product available in the US ‘shortly’. This should allow GSK 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.

Ben Hargreaves

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