GlaxoSmithKline ($GSK) CEO Andrew Witty recently said slow-starting respiratory newcomer Breo was finally gaining some market traction. And now, it has a new asthma indication the company hopes can help speed things along.
Thursday, the FDA green-lighted the blockbuster wannabe to treat asthma in patients 18 years and older. Concerning GSK's proposed use in younger patients, though, the agency issued a complete response letter. In 12- to 17-year-olds, the company's data suggested that the risks of approval weren't worth the benefits, it said.
That verdict comes as no surprise following a March advisory committee meeting that saw a panel of experts vote 16-4 in favor of approving Breo in adults and 19-1 against approval in the younger population.
But Glaxo, which is preparing to fill a giant revenue hole that respiratory behemoth Advair will leave, will take what it can get. The $8 billion-a-year seller has already begun its downward spiral, with competition from rivals--including AstraZeneca ($AZN)--taking its toll on both sides of the pond, and the $110 million in revenue Breo raked in last year is not going to be enough to keep sales afloat.
|GlaxoSmithKline CEO Andrew Witty|
Even before the new, nod, though, Witty said the drug--and fellow new respiratory entry Anoro--were showing signs of life, highlighting improved payer coverage.
"I am not saying to you on this call (that) I hope to see market share increase for respiratory--I am telling you the market shares have begun to go up in the last few weeks," he told investors on a February conference call.
What he couldn't guarantee, though, was that the momentum would continue, cautioning that he couldn't predict "exactly how that is going to play out for the rest of the year."
- read Glaxo's release
Special Reports: The top 15 companies by 2014 revenue - GlaxoSmithKline | The 10 best-selling drugs of 2013 - Advair/Seretide