Takeda Positions Uloric To Gout Patients In Need Of Better Control
Takeda will focus its initial marketing effort for Uloric (febuxostat) - the first new treatment for gout in more than 40 years - on health care providers whose patients have highly elevated uric acid levels or continue to experience painful flares despite being on treatment
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FDA already issued a warning based on preliminary data from the CARES outcomes study, but now the final results of the confirmatory trial are in and show higher risk for cardiovascular death for Uloric compared with generic allopurinol.
FDA committee members generally reject the notion that dedicated safety studies are not possible for peripherally active mu opioid receptor antagonists in chronic pain patients, but acknowledge a low background cardiovascular risk and symptomatic nature of opioid-induced constipation make such trials problematic. The advisors’ opinions on the practicality of such trials in low-risk patients with symptomatic conditions could have implications beyond PAMORAs.
Takeda announced June 27 that U.S. FDA had denied approval of its type 2 diabetes agent alogliptin, a potential blockbuster poised to compete with similar molecules from Merck and the team of Bristol-Myers Squibb and AstraZeneca. The setback will delay alogliptin's launch by at least three years - and possibly longer - depending on the additional studies required by regulators