An FDA Advisory Panel has given Takeda’s Uloric (febuxostat) for the treatment of gout. Uloric is the first new treatment for gout in over 40 years. This was round two for Uloric, after having gone through review back in 2004.
Safety questions continue to plague the product. If the FDA heeds the recommendation of its Advisory Committee (not a certainty), it will likely require additional post-marketing safety studies.
Takeda and its former joint venture TAP Pharmaceuticals have been researching gout for years, but the holy grail of product approval and clean trials have eluded them.
If Uloric gets a clean approval, the product does offer real, significant patient benefits. But it’s still going to be an uphill battle to get there.
Safety questions continue to plague the product. If the FDA heeds the recommendation of its Advisory Committee (not a certainty), it will likely require additional post-marketing safety studies.
Takeda and its former joint venture TAP Pharmaceuticals have been researching gout for years, but the holy grail of product approval and clean trials have eluded them.
If Uloric gets a clean approval, the product does offer real, significant patient benefits. But it’s still going to be an uphill battle to get there.