The FDA’s Friday approval of GlaxoSmithKline’s drug Breo just made the COPD therapy market more crowded, and GSK’s marketing strategy more complex.
The regulator’s approval of the once-a-day medication follows an advisory committee’s April 17 thumbs-up for the medication, which will now have to fight for formulary space and physician mindshare amid peers including AstraZeneca’s Symbicort and GSK’s own Advair. GSK said in a statement it expects the drug to hit the US market during the third quarter. It is the first once-daily inhaled corticosteroid/long-acting beta-two agonist.
Breo, which was approved along with the Ellipta inhaler, is known as Relvar in Europe. Bernstein analyst Tim Anderson wrote in April that the drug could have about $700 million in sales by 2016. He also said the drug’s potential is limited, in that it’s unlikely the drug maker will be able to land an additional indication, such as asthma, unlike the older, entrenched competition.
