Advanced Search
Current and Breaking News for Professionals, Consumers and Media



Click here to learn how to advertise on this site and for ad rates.

FDA Approval Author: Staff Editor Last Updated: Sep 7, 2017 - 10:06:33 PM



FDA Approves New Psoriasis Drug

By Staff Editor
Feb 15, 2017 - 7:22:44 PM



Email Newsletter icon, E-mail Newsletter icon, Email List icon, E-mail List icon Sign up for our Ezine
For Email Marketing you can trust


Email this article
 Printer friendly page

(HealthNewsDigest.com) - SILVER SPRING, Md., Feb. 15, 2017 -- The U.S. Food and Drug Administration today approved 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 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, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment."

Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35. The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales.

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 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. 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.

Suicidal ideation and behavior, 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 behavior compared to users without this history. A causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established.

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. 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 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 is also approved with a Medication Guide to inform patients of the risk of suicidal ideation and behavior, 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 immunizations 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, diarrhea, 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.

For more information:

FDA Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

NIH: Psoriasis
http://www.nlm.nih.gov/medlineplus/ency/article/000434.htm

###



Top of Page

HealthNewsDigest.com

FDA Approval
Latest Headlines


+ FDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements
+ FDA Approves New Treatment to Reduce the Risk of Breast Cancer Returning
+ FDA Unveils Plan to Eliminate Orphan Designation Backlog
+ FDA Investigates Findings of Hepatitis A Linked to Frozen Tuna
+ FDA Approves New Novo Nordisk Treatment for Patients with Hemophilia
+ FDA Approves First Cancer Treatment for Any Solid Tumor With a Specific Genetic Feature
+ FDA Approves Drug to Treat ALS
+ FDA Approves Urea Cycle Disorder Treatment for Use in Children as Young as Two Months
+ Novartis Receives FDA Approval for Rydapt® in Newly Diagnosed FLT3-mutated Acute Yeloid Leukemia (AML)
+ FDA Approves New Combination Treatment for Acute Myeloid Leukemia



Contact Us | Job Listings | Help | Site Map | About Us
Advertising Information | HND Press Release | Submit Information | Disclaimer

Site hosted by Sanchez Productions