New biologic drug wins FDA approval

| Melissa Leavitt

Earlier this week, the U.S. Food and Drug Administration (FDA) approved Siliq (brodalumab) for the treatment of moderate to severe plaque psoriasis. Siliq is an injectable biologic medication.

According to clinical trial results, the drug can deliver speedy improvement to some people with psoriasis. Findings from a Phase III trial showed that, after three months on the drug, up to 83 percent of people experienced at least a 75 percent improvement in psoriasis. In the same trial, up to 42 percent of people with psoriasis experienced completely clear skin in the same amount of time.

Studies also suggest that Siliq could effectively treat psoriasis in specific locations, too, such as on the nails and scalp.

Siliq has been approved with what is known as a "boxed warning” in response to concerns of suicidal ideation and behavior that emerged during the clinical trials.

The FDA press release announcing Siliq’s approval noted, “a causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established.”

However, the warning requires patients on the drug to participate in a program intended to mitigate suicide risk.

"Because of the observed risk of suicidal ideation and behavior, the labeling 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," as stated in the FDA’s press release.

The statement goes on to list requirements of the program, stating,

  • "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 behavior, feelings of depression, anxiety or other mood changes."
  • "Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Siliq."

Siliq targets a cytokine known as interleukin-17 (IL-17). Cytokines are inflammatory proteins that contribute to inflammation in psoriasis. IL-17 is a key driver in psoriasis, and blocking it can be a highly effective treatment. Two other drugs that target IL-17, Cosentyx (secukinumab) and Taltz (ixekizumab), are already available to patients.

Siliq, which is being marketed in the U.S. by Valeant Pharmaceuticals, represents a new option for people with moderate-to-severe psoriasis in search of a different treatment approach.

Despite the growing availability of treatments for psoriasis and psoriatic arthritis in recent years, many people with psoriatic disease — including up to 55 percent of people with moderate to severe psoriasis — are not treating their disease to their level of severity.

The National Psoriasis Foundation encourages federal and state policymakers to expand treatment options for people with psoriatic disease. In March 2016, the NPF supported a day-long meeting at the FDA focused exclusively on drug development for psoriasis. More than 200 individuals living with psoriasis and their caregivers offered their perspectives to the FDA on the most frustrating symptoms of psoriasis and what they are looking for in treatments. People with psoriasis who participated in the meeting noted that a drug’s effectiveness, access to the drug and the possibility of side effects were all important issues they considered when choosing a treatment.

Talk to your health care provider about finding the right treatment option for your psoriatic disease. If you have questions about treatment, or need help finding a provider for your psoriatic disease, contact NPF’s Patient Navigation Center. Click here for more information.

 


Driving discovery, creating community

For more than 50 years, we’ve been driving efforts to cure psoriatic disease and improve the lives of those affected. But there’s still plenty to do! Learn how you can help our advocacy team shape the laws and policies that affect people with psoriasis and psoriatic arthritis – in your state and across the country. Help us raise funds to support research by joining Team NPF, where you can walk, run, cycle, play bingo or create your own fundraising event. If you or someone you love needs free, personalized support for living a healthier life with psoriatic disease, contact our Patient Navigation Center. And keep the National Psoriasis Foundation going strong by making a donation today. Together, we will find a cure.

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