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 Trelegy Ellipta is the first once-daily triple medicine for chronic
obstructive pulmonary disease (COPD), putting Britain's biggest
drugmaker ahead of rivals such as AstraZeneca and Novartis .
Last week, the inhaler, which GSK developed with Innoviva, also won
a recommendation for approval from the European Medicines Agency.
Chief Executive Emma Walmsley sees the triple lung drug as one of
three "critical" launches as GSK seeks to fill a revenue gap left by
falling sales of Advair, which is expected to face U.S. generic
competition sometime next year.
Its two other key new products are Shingrix, a shingles vaccine that
was unanimously recommended for approval by a U.S. Food and Drug
Administration (FDA) advisory panel last week, and a novel dual-drug
regimen for HIV.
GSK estimates about a quarter of COPD patients are already using
three drugs to control their lung disease, suggesting plentiful
demand for more intensive treatment.
Such patients will now get all three medicines in one easy-to-use
inhaler, although how exactly that will translate into overall sales
is less easy to calculate.
The new product is likely to be attractive in some markets, since it
will reduce co-payments for patients by offering a single
prescription, but GSK will inevitably cannibalize sales of some of
its other drugs.
At the same time, prices for inhaled respiratory medicines are
continuing to decline due to increased competition.
Still, by launching Trelegy Ellipta before generic Advair hits the
U.S. market, GSK will have more breathing space to switch patients
to the newer product, Berenberg analysts said in a note.
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GSK, whose shares were little changed in early trade on Tuesday
following overnight news of the FDA approval, said it would make
Trelegy Ellipta available in the United States "shortly".
The GSK inhaler combines the drugs fluticasone furoate, umeclidinium
and vilanterol, offering three different mechanisms to help open
airways of patients with severe COPD. The drug is not indicated for
asthma.
GSK has been the respiratory market world leader since launching its
Ventolin inhaler in 1969 and Walmsley, who took over as CEO in
April, has made lung disease a continuing priority for the years
ahead.
In July, she announced plans to narrow the focus of the group's drug
research and allocate 80 percent of its R&D budget to respiratory
and HIV/infectious diseases, along with two other potential areas of
oncology and immuno-inflammation.
(Additional reporting by Rama Venkat Raman in Bengaluru; Editing by
Leslie Adler and Louise Heavens)
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