US FDA OKs removal of safety warning on GSK's combo asthma drugs

By Gareth Macdonald

- Last updated on GMT

GSK corporate headquarters in Brentford, UK (Source GSK website)
GSK corporate headquarters in Brentford, UK (Source GSK website)

Related tags Asthma Pharmaceutical drug

The US FDA has cleared GSK to remove the box warning from its combination asthma drugs Breo Ellipta, Advair diskus and Advair HFA after safety data.

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​.”

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