Drugs

FDA Panel Finds Continued Benefit for Takeda’s Uloric

A joint meeting of the FDA Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee has voted 19 to 2 that based on its benefit-to-risk profile there is a patient population with gout that exists for Takeda’s Uloric (febuxostat) for its current indication as first-line treatment for hyperuricemia, despite concerns about cardiac deaths. Panel members at the 1/11 meeting discussed 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 (CARES trial) focused on cardiovascular risk.

The briefing document said 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 Public Citizen submitted a 6/21/18 citizen petition asking that Uloric be withdrawn from the market based on the CARES study findings.

In discussing Uloric’s cardiovascular safety, several panelists recommended regulatory actions such as an additional Black Box warning and making the drug a second-line therapy after allopurinol. Additionally, creating a restrictive Risk Evaluation and Mitigation Strategy (REMS) was suggested, but FDA attendees hinted that a REMS would be unlikely.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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