GlaxoSmithKline (GSK) said on Friday that a European Medicines Agency (EMA) panel has recommended the company’s three-in-one inhaled lung drug.
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.
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)