Good news for GlaxoSmithKline ($GSK): An FDA panel of experts says the efficacy and safety data for blockbuster wannabe Breo support the asthma indication it's gunning for in adults 18 and older. When it comes to children aged 12 to 17, though? The panelists aren't having it.
On Thursday, the agency's advisory committee voted 16-4 in favor of green-lighting the med to treat asthmatic adults. But when it came to assessing Breo in younger patients, it turned the drug down by an 18-2 measure--and one of the two "yes" votes was cast accidentally, the FDA said.
Even if the FDA does follow the committee's lead and expand Breo's label in adults--a decision that's due by the end of April--its nod may come with some caveats. The panel voted in favor of requiring a large LABA safety trial for the drug, similar to the ongoing trials the FDA requires for on-the-market asthma meds like Glaxo's aged Advair.
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| GlaxoSmithKline CEO Andrew Witty |
Still, it's a good sign for Glaxo, which is hoping the asthma approval can help slow-starter Breo really get moving. The med is one of a handful of respiratory up-and-comers that'll need to produce for the pharma giant if it hopes to even approach filling the giant shoes of $8-billion-a-year Advair, whose downward spiral has already begun.
Meanwhile, though, GSK chief Andrew Witty says the therapy--and fellow respiratory new kid Anoro--are picking up steam in the COPD market. "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 conference call last month.
Whether that can last, though, remains to be seen. "What I am not guaranteeing is exactly how that is going to play out for the rest of the year," he said.
- read Glaxo's release
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