GlaxoSmithKline PLC (LON:GSK) has been dealt a major blow after a US Food and Drug Administration advisory committee failed to give its backing to the drugs giant’s chronic obstructive pulmonary disorder treatment.
The FTSE 100 group’s Nucala drug has already been approved as a treatment for asthma, but GSK thinks it could also work in patients experiencing a sudden worsening of COPD.
The committee disagreed though, with 16 of the 19 members voting not to support approval, with the same number agreeing that there was “not substantial evidence of the efficacy”. They did, however, agree that the drug was safe.
As the name suggests, the advisory committee shares its thoughts with FDA regulators, but their recommendations are not binding.
That said, it would be unusual for the FDA to go against the committee, especially when the outcome is so clear.
As part of its report, the committee suggested that GSK go away and get some more data to show which patient population would be more likely to benefit.
GSK still confident
“Having participated in today's advisory committee meeting and heard the recommendation we will continue to work with the FDA to address outstanding questions,” said GSK’s senior vice president of respiratory R&D, Dave Allen.
“We remain confident our data supports mepolizumab as a targeted treatment for patients continuing to experience COPD exacerbations guided by blood eosinophil count.”
It is a blow for Glaxo and its boss, Emma Walmsley, who made respiratory drugs one of the company’s three core therapeutic areas of focus when she took the job almost a year ago.
Nucala generated sales of £141mln in the three months to the end of June. If it was approved for use in COPD, sales could potentially surge, as the disease affects almost 400mln people around the world.
Shares were down 3.7% at 1,485p in late morning trading.