FDA Green Lights GSK’s Breo Ellipta for Adults With Asthma
The FDA has granted British drug giant GlaxoSmithKline an asthma indication for another drug meant to be used with its Ellipta dry powder inhaler.
Breo Ellipta, a combination of the corticosteroid fluticasone furoate and long-acting beta2-agonist vilanterol, will now be available as a once-daily treatment for adults with asthma. It joins Arnuity Ellipta (fluticasone furoate), which was approved last summer for asthma patients ages 12 and older.
Unlike Arnuity, however, Breo Ellipta can’t be given to patients between the ages of 12 and 17. GSK spokesman Juan Carlos Molina said the company had hoped to market the drug to this age group but received a complete response letter from the FDA saying there weren’t enough trial participants aged 12 to 17 to conduct a reasonable risk-benefit analysis.
The agency asked GSK to provide additional data showing Breo’s benefits outweigh its risks in this age group, Molina says.
GSK hopes the addition of Breo to the list of available asthma therapies for adults will help more patients keep their asthma under control. The disease affects 26 million people in the U.S., nearly half of whom aren’t able to control their asthma with available therapies, Molina says.
Breo, Anoro (umeclidinium and vilanterol inhalation powder) and Incruse (umeclidinium inhalation powder) are already indicated to treat chronic obstructive pulmonary disease. — Lena Freund