GlaxoSmithKline has announced that a European Medicines Agency (EMA) panel has recommended the company’s three-in-one inhaled lung drug, Advair. Reuters Health reports that 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 US-listed Innoviva received a positive opinion for the treatment from the EMA’s Committee for Medicinal Products for Human Use (CHMP), GSK said. The report says a CHMP positive opinion is one of the final steps before marketing authorisation 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 $1bn 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 US this year as, so far, generic competitors have failed to win US approval for the cut-price equivalent form of the medicine. Approval is expected by mid-2018.
The report says GSK’s new CEO announced plans in July to allocate 80% 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.
[link url="https://www.reuters.com/article/us-gsk-copd-approval/gsks-three-in-one-inhaler-gets-positive-opinion-from-eu-agency-idUSKCN1BQ0M0"]Reuters Health report[/link]