A recent FDA panel vote over AstraZeneca's ($AZN) gout candidate may have gone the drugmaker's way, but safety concerns and a dearth of clear-benefit evidence may trip it up in the market if regulators ultimately give it a green light.
Experts voted 10-4 in favor of approving the prospect, dubbed lesinurad, AZ said Friday. And while they unanimously agreed that a combo of lesinurad and a generic first-line treatment can improve gout symptoms, they split 7-6--with one abstention--when asked whether the med's safety profile merited a go-ahead from regulators.
According to developer Ardea Biosciences--acquired by AZ for $1.26 billion in 2012--that risk-benefit profile is good enough to hack it as an add-on treatment to Takeda and Ipsen's febuxostat. Lesinurad was not intended as a first-line gout therapy, it told Reuters Friday.
And the FDA tends to follow advisory committee recommendations, which is good news for the British pharma giant. Bernstein analyst Tim Anderson has projected 2020 sales of $582 million for the drug, and other analysts have said a global rise of gout could spike sales past the blockbuster benchmark.
But if the wannabe does win the FDA's favor, it may still run into trouble with payers. In June, it posted Phase III results showing that its 200-mg dose--the one the FDA is currently evaluating--in tandem with febuxostat outperformed solo febuxostat "at all months except at the time of the primary endpoint." AZ also lacks clear evidence of improvement over 50-year-old generic allopurinol, meaning it may have a hard time convincing payers to open their pockets.
But allopurinol, for one, has safety issues of its own, Reuters points out. It's known to have rare--but potentially fatal--adverse effects involving skin.
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