Drugs

FDA Reviewers Have Safety Concerns With Valeant Psoriasis Drug

FDA reviewers say data contained in a Valeant Pharmaceuticals BLA for Siliq (brodalumab) injection for treating adults with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy showed that the therapy was superior to placebo in reducing psoriasis severity after 12 weeks of treatment. The BLA is the subject of a 7/19 FDA Dermatologic and Ophthalmic Drugs Advisory Committee meeting.

The reviewers also note that there are some safety concerns with the submission. “In the Phase 3 clinical trials of psoriasis, a total of 23 treatment-emergent fatal events were reported in brodalumab-treating subjects,” an agency briefing document notes. “The largest category was comprised of 13 cardiovascular-related events, including MI (four), sudden death/cardiac arrest (three), cerebrovascular accident (two), and other single events (four). There were a total of four completed suicides, including one reported as an intentional overdose, three accidental deaths related to motor vehicle accidents and three other single unrelated fatal events.”

The document says that a comprehensive evaluation of suicidal ideation and behavior (SIB) was undertaken by both Valeant and the agency and will be discussed at length during the advisory committee meeting. The committee will also discuss several risk management options. One caveat, according to the reviewers, is that risk management strategies “may not prevent the risk of suicide in an individual treated with brodalumab. Tools may increase awareness and detection but cannot fully predict the act of committing suicide. The relationship between SIB and administration of brodalumab is unpredictable, with events occurring across all timeframes after initiating treatment. Given the above discussion, even the most restrictive REMS may be limited in effectively mitigating the risk of SIB in the postmarketing setting, should brodalumab be approved.”

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