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 GSK's once-daily triple inhaler combines the drugs fluticasone
furoate, umeclidinium and vilanterol. The idea is to use three
different mechanisms to help open airways of patients with severe
chronic obstructive pulmonary disease (COPD).
GSK and U.S.-listed Innoviva received a positive opinion for the
treatment from the EMA's Committee for Medicinal Products for Human
Use (CHMP), GSK said in a statement.
A CHMP positive opinion is one of the final steps before marketing
authorization from the European Commission. A final decision is
expected around the end of 2017, the company said.
GSK's former blockbuster lung drug Advair, which has generated more
than $1 billion in annual sales for the company since 2001, has
already been facing generic competition in Europe.
However, the company is likely to escape generic competition in the
United States this year as, so far, generic competitors have failed
to win U.S. approval for the cut-price equivalent form of the
medicine. Approval is expected by mid-2018.
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GSK's new chief executive announced plans in July to allocate 80
percent of its R&D budget in the future to respiratory and
HIV/infectious diseases, along with two other potential areas of
oncology and immuno-inflammation.
(Reporting by Arathy S Nair in Bengaluru; editing by David Clarke
and Jason Neely)
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