GlaxoSmithKline (GSK) and Theravance have won US FDA approval for respiratory drug Breo for asthma in adults, but not in children.
The decision to limit use of the Breo (fluticasone furoate/vilanterol) to patients aged 18 years and older was expected after an FDA advisory committee voted in March not to recommend approval in younger patients.
The reluctance stems from longstanding caution at the FDA about the safety of long-acting beta agonists and inhaled corticosteroids, so the approval of the combination in adults – after a five-year hiatus – is something of a step forward even with the exclusion of children from the label.
The FDA has already asked GSK and Theravance to carry out additional studies to show its safety in the paediatric setting. Analysts have suggested that adults remain the largest market segment however, adding that approval in asthma should help Breo top the $1bn threshold by 2020.
Breo – a follow-up to GSK’s big-selling Advair (fluticasone propionate/salmeterol) brand – has been approved as a once-daily therapy and is the second asthma drug to be approved in the US from GSK in the last year after Arnuity (fluticasone furoate) got the nod last August.
The green light in asthma comes two years after Breo was approved by the US regulator as a treatment for chronic obstructive pulmonary disease (COPD)
Breo and other new drugs such as Anoro (umeclidinium bromide/vilanterol) have been positioned as successors to Advair, which saw sales slip 15% to a little over £4.2bn ($6.35bn) last year – although increasing competition and downward pricing pressure in the respiratory market has pegged back the growth of its respiratory franchise.
Analysts predict that GSK’s new combination asthma and COPD drugs and those from competitors such as Novartis and Boehringer Ingelheim are more likely to sell in the $1bn-$2bn range, a step down from Advair’s performance at peak.
With that in mind, GSK and Theravance have started developing a triple therapy – based on fluticasone, umeclidinium and vilanterol delivered via a single device – that they hope will show sufficient improvement over dual therapy rivals to set a new standard respiratory therapy.