Posted from: Wednesday, August 02, 2017 - 01:26 PM - Present

Tremfya Approved for Psoriasis

July 13, 2017 – The U.S. FDA has approved Tremfya™ (guselkumab), manufactured by Janssen, for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic or phototherapy. Tremfya is a biologic in a new class of medications that inhibit interleukin (IL)-23. It is delivered by subcutaneous injection and will be available in prefilled 100mg/mL syringes. After the initial doses at weeks 0 and 4, it is administered every 8 weeks.

Psoriasis is a chronic immune system disease that causes an overproduction of skin cells. Plaque psoriasis, which affects approximately six million patients in the U.S., is characterized by red, scaly patches on the skin. Tremfya’s approval was based on clinical trials that demonstrated improved skin clearance compared to AbbVie’s Humira® (adalimumab), Janssen’s Stelara® (ustekinumab), and a placebo.

Janssen plans to have launched Tremfya for treatment of plaque psoriasis before the close of July 2017. The drug is currently in Phase III development for the treatment of patients who have active psoriatic arthritis, and may receive approval for this expanded indication in 2018.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Sunday, November 19, 2017 - 07:53 PM.