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February 16, 2017

Valeant Psoriasis Drug Gets FDA Nod with Boxed Warning

  • The FDA approved Valeant Pharmaceuticals’s injectable plaque psoriasis therapy SiliqTM (brodalumab), but with a black box warning of suicidal ideation and behavior. Siliq availability will also be restricted through a Risk Evaluation and Mitigation Strategy (REMS) program. "Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment,” said Julie Beitz, M.D., director of FDA’s Office of Drug Evaluation III, Center for Drug Evaluation and Research.

    Siliq is an interleukin-17 (IL-17) receptor-targeting monoclonal antibody that is designed to block inflammatory signals. The drug is indicated for patients who have failed to respond or have stopped responding to other systemic therapies. FDA approval was based on data from the AMAGINE program, which included three pivotal trials in 4373 adult patients with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy.

    Siliq was originally developed at Amgen, and partnered with AstraZeneca in 2012. Concerns about suicidal ideation and behavior associated with brodalumab therapy led Amgen to drop the drug in May 2015 and pass on all rights to AstraZeneca.

    Quebec-based Valeant negotiated exclusive rights from AstraZeneca in September 2015 to develop brodalumab globally, except in Japan and certain other Asian countries,. Valeant paid the U.K. drugmaker $100 million upfront in a deal that included prelaunch milestones of up to $170 million and potentially another $175 million in sales milestones.

    FDA approval of Siliq has triggered a $130 million milestone payment to AstraZeneca from Valeant. The firms will share profits from U.S. sales of the drug. Valeant chairman and CEO Joseph C. Papa said his firm believed Siliq fulfills “a significant unmet medical need."

    In July 2016, Valeant gave up European rights to brodalumab, which AstraZeneca passed on to Leo Pharma. In a July 2016 briefing document to FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC), Valeant reported that across all indications in the brodalumab development program there were 39 patients with suicidal ideation and behavior, including six completed suicides.

    Valeant is separately developing a topical psoriasis therapy, IDP-118. The lotion formulation combines approved plaque psoriasis drugs halobetasol propionate and tazarotene. Last month the firm reported positive data from a second, confirmatory Phase III study evaluating IDP-118 in 203 adult patients with moderate-to-severe plaque psoriasis.

    Also in January, Valeant agreed a $819.9 million cash deal for the sale of its majority stake in Dendreon to Sanpower Group. On the same day L’Oreal announced that it had agreed to buy three skincare brands from Valeant for  $1.3 billion

     

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