Drugs

Advisors to Look at Uloric Safety

Members of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss 1/11 a sNDA for Takeda’s Uloric (febuxostat) in light of results of an FDA-mandated postmarketing safety trial (CARES) evaluating the drug’s cardiovascular safety. An agency briefing document released in advance of the meeting says Uloric was approved 2/2009 following three review cycles. It was rejected twice due to concerns involving cardiovascular safety and death. One of the conditions of its approval was a post-marketing safety trial focused on cardiovascular risk.

The document says Takeda informed FDA in 10/2017 of the results of the preliminary analysis from CARES showing a significant increase in cardiovascular death and all-cause death in Uloric compared with another gout drug (allopurinol). The agency issued a 11/15/17 Drug Safety Communication on the risk of cardiovascular death and all-cause death based on the preliminary report. The final study report was submitted 1/19/18. Public Citizen submitted a 6/21/18 citizen petition asking that Uloric be withdrawn from the market based on the CARES study findings.

Members of the two committees are asked to discuss the CARES results and the strength of the findings for cardiovascular mortality as well as the benefits of the drug and the benefit/risk assessment.

The members are asked to determine whether the Uloric benefit/risk profile has changed due to the CARES results and what regulatory options may be appropriate for the agency to use to address the findings.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome