text_1: FDA approves new psoriasis drug
text_2: The US Food and Drug Administration just approved a new drug to treat psoriasis, a common skin condition that can form thick, silvery scales and itchy, dry, red patches. Siliq (brodalumab) is mainly intended for patients who don’t respond to other forms of treatment, like anti-inflammatory topical medications and light therapies. The “last resort” recommendation may be due to the four completed suicides that took place during the clinical trial, leading the FDA to believe that Siliq may be correlated to an increased risk of suicidal ideation and behavior — especially in patients with a history of depression. As a result, the FDA is requiring Siliq to be sold with a “boxed warning” (the strictest warning put in the labeling of prescription drugs) and only through a restricted program. The FDA news release devotes a significant chunk to the drug’s potential harms and makes clear who should or shouldn’t be taking Siliq. What’s mainly missing from the release are any numbers to give a sense of the scope of potential benefits and harms. Regarding the drug’s potential benefits, the release uses only vague, comparative wording (“more patients… had skin that was clear or almost clear.”). We don’t know how the participants were selected, how long they were followed up and how their improvement was assessed. Furthermore, a clinical trial was stopped for a period of time due to safety concerns, which was then continued by another drug manufacturer. Although not explicitly stated, it is fair to assume that drug manufacturers also funded these clinical trials. These are study limitations that were never disclosed by the news release. We did find a 90-page FDA briefing document online from 2016, which includes some efficacy data. Curiously, this document mentions five clinical trials instead of three. We’re not sure why the FDA release didn’t include the two other clinical trials that compared Siliq (brodalumab) to ustekinumab. We also reviewed TIME.com’s coverage of this new drug. Specialty drugs treating skin conditions like psoriasis can be expensive. The main competitors to Valeant’s Siliq may be Novartis’ Cosentyx and Eli Lilly’s Taltz — both of which cost at least $16,600 for one dose. Although some of this could be covered by insurance, patients could still be responsible for co-pays, which could amount to thousands of dollars. In addition, if patients have exhausted all existing treatment options and are desperate to clear up their psoriasis, they may be willing to try riskier therapies. If there is a new alternative that is FDA-approved and cost-effective, then it certainly deserves to be reported — as in this case, with strong caveats.