FDA Approves Brodalumab to Treat Psoriasis

27 Feb 2017 05:52 Rassegna stampa

The US Food and Drug Administration (FDA) has approved brodalumab (Siliq) to treat adults with moderate-to-severe plaque psoriasis. Brodalumab is administered as an injection.

Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy 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, FDA's Center for Drug Evaluation and Research, Rockville, Maryland. "Patients and their healthcare providers should discuss the benefits and risks of [brodalumab] before considering treatment."

Brodalumab binds to a protein that causes inflammation, inhibiting the inflammatory response that plays a role in the development of plaque psoriasis.

Brodalumab safety and efficacy were established in three randomized, 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. Compared with placebo, more patients treated with brodalumab had skin that was clear or almost clear, as assessed by scoring of the extent, nature, and severity of psoriatic changes of the skin.

Suicidal ideation and behaviour, including completed suicides, have occurred in patients treated with brodalumab during clinical trials. Brodalumab users with a history of suicidality or depression had an increased incidence of suicidal ideation and behaviour compared with users without this history. A causal association between treatment with brodalumab 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 brodalumab includes a Boxed Warning and the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the brodalumab REMS Program. Notable requirements of the brodalumab 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 brodalumab.

Brodalumab is also approved with a Medication Guide to inform patients of the risk of suicidal ideation and behaviour, and that because brodalumab 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 brodalumab. Healthcare providers should also evaluate patients for tuberculosis (TB) infection prior to initiating treatment with brodalumab. Healthcare providers should not administer brodalumab to patients with active TB infection, and should avoid immunizations with live vaccines in patients being treated with brodalumab.

The most common adverse reactions reported with the use of brodalumab include arthralgia, headache, fatigue, diarrhoea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea.

SOURCE: US Food and Drug Administration

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