FDA approves new psoriasis drug that induced suicide in trial
Posted: 17 February 2017 | | No comments yet
The US Food and Drug Administration (FDA) has approved Valeant’s Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet light […]
Siliq is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet light treatment) and have failed to respond, or have stopped responding to other systemic therapies.
“Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today’s approval provides patients with another treatment option for their psoriasis,” said Julie Beitz, MD director of the Office of Drug Evaluation III in the FDA’s Centre for Drug Evaluation and Research.
“Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment.”
Siliq’s active ingredient (brodalumab) binds to a protein that causes inflammation, inhibiting the inflammatory response that plays a role in the development of plaque psoriasis.
Siliq’s safety and efficacy were established in three randomised, placebo-controlled clinical trials with a total of 4,373 adult participants with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. More patients treated with Siliq compared to placebo had skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.
Dangerous adverse effects
Suicidal ideation and behaviour, including completed suicides, have occurred in patients treated with Siliq during clinical trials. Siliq users with a history of suicidality or depression had an increased incidence of suicidal ideation and behaviour compared to users without this history.
A causal association between treatment with Siliq and increased risk of suicidal ideation and behaviour has not been established.
Because of the observed risk of suicidal ideation and behaviour, the labelling for Siliq includes a Boxed Warning and the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Siliq REMS Program.
Notable requirements of the Siliq REMS Program include the following:
- Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
- Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behaviour, feelings of depression, anxiety or other mood changes.
- Pharmacies must be certified with the program and must only dispense to patients who are authorised to receive Siliq.
Siliq is also approved with a Medication Guide to inform patients of the risk of suicidal ideation and behaviour, and that because Siliq is a medication that affects the immune system, patients may have a greater risk of getting an infection, or an allergic or autoimmune condition.
Patients with Crohn’s disease should not use Siliq.
Health care providers should also evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Siliq. Health care providers should not administer Siliq to patients with active TB infection, and should avoid immunisations with live vaccines in patients being treated with Siliq.
The most common adverse reactions reported with the use of Siliq include joint pain (arthralgia), headache, fatigue, diarrhoea, throat pain (oropharyngeal pain), nausea, muscle pain (myalgia), injection site reactions, influenza, low white blood cell count (neutropenia) and fungal (tinea) infections.
Siliq is marketed by Bridgewater, New Jersey-based Valeant Pharmaceuticals.