US FDA OKs removal of safety warning on GSK's combo asthma drugs
The decision comes seven years after the US regulator asked manufacturers of drugs combining a long-acting beta agonist (LABA) with an inhaled corticosteroid (ICS) to add warning labels.
The agency also asked the manufacturers to conduct post-market clinical trials to test if the combination products were as safe as ICS alone.
GSK was one of several companies to submit data from large-scale safety trials.
The results showed the combination products were not associated with additional risks in any of the patient populations studied.
A company spokeswoman told us “This was a post marketing requirement from the FDA for manufacturers of LABA-containing medicines, to each conduct a large-scale study on the safety of LABAs when used in combination with ICS.”
She added that: “Today’s announcement is positive for the class, but unlikely to impact on sales or production. Physicians have been treating patients with asthma this class for over a decade.”
