Dupixent Approved for Atopic Dermatitis

March 28, 2017 – The U.S. FDA approved Dupixent® (dupilumab) manufactured by Sanofi and Regeneron. Dupixent is indicated for treating adults who have moderate-to-severe atopic dermatitis that is not responding to topical therapy. Atopic dermatitis is a chronic inflammatory disease that results in cracked, dry, itchy or oozing skin. Dupixent is an interleukin-4 alpha receptor (IL-4Rα) blocker -- an antibody that disrupts the inflammatory process. Dupixent will be given as subcutaneous injections. After the first dose of 600mg (two injections at the same time but at different injection sites), recommended dosing is 300mg once every two weeks. It can be used along with topical steroids, but the concurrent use of topical calcineurin inhibitors with Dupixent should be reserved for sensitive skin, such as the face or genital areas. It will be dispensed in pre-filled, single-dose syringes. 

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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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.