Blog

Dupixent (dupilumab) Approved

FDA approves new eczema drug Dupixent

The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

“FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies.”

Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as “eczema,” which is a general term for several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema; onset typically begins in childhood and can last through adulthood. The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy. Scratching leads to swelling, cracking, “weeping” clear fluid, and finally, coarsening and thickening of the skin.

Dupixent is administered as an injection under the skin. Dupixent’s active ingredient is an antibody (dupilumab) that binds to a protein [interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra)], that causes inflammation. By binding to this protein, Dupixent is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis.

The safety and efficacy of Dupixent were established in three placebo-controlled clinical trials with a total of 2,119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s). Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment.

Dupixent can cause side effects such as serious allergic reactions and eye problems, such as pink eye (conjunctivitis) and inflammation of the cornea (keratitis). If patients experience new or worsening eye symptoms such as redness, itching, pain or visual changes, they should consult a health care provider. The most common side effects include injection site reactions; cold sores in the mouth or on the lips; and eye and eyelid inflammation, including redness, swelling and itching.

The safety and efficacy of Dupixent have not been established in the treatment of asthma. Patients who also have asthma should not adjust or stop their asthma treatment without talking to their physicians.

The FDA granted the application for Dupixent Priority Review and Breakthrough Therapy designation.

The FDA granted the approval of Dupixent to Regeneron Pharmaceuticals, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

AHFS Clinical Drug Information Now Available

AHFS-CDI-200x242-revisedJust launched, AHFS Clinical Drug Information (AHFS CDI) is your comprehensive interactive treatment and drug therapy solution. It allows health professionals to quickly access the nation’s leading compendium of unbiased and authoritative drug information as well as other drug databases. Access real-time drug and safety alerts, including current drug shortages information. Available on a Google cloud-based platform for any mobile device, as well as an app for iOS devices, with Android coming soon.

 

View the new video to learn more about AHFS CDI.

 

AHFS Patient Medication Information Update – March 2017

The March update to the AHFS Patient Medication Information (PMI) database has been published. Highlights of the update include:

New PMI Monographs

  • Hydrocortisone Rectal (Anusol HC®, Colocort®, Cortenema®, Preparation H Anti-Itch®, Proctocort®, Proctofoam HC®)
    • Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum).
  • Lixisenatide Injection (Adlyxin®)
    • Lixisenatide injection is used along with diet and exercise to treat type 2 diabetes.
  • Cromolyn Ophthalmic (Crolom®)
    • Cromolyn ophthalmic is used to treat the symptoms of allergic conjunctivitis (a condition in which the eyes become itchy, swollen, red, and teary when they are exposed to certain substances) and keratitis (a condition that causes swelling of the cornea [tissue in the front of the eye] that causes eye redness, pain, and tearing and changes in vision).
  • Bezlotoxumab Injection (Zinplava®)
    • Bezlotoxumab injection is used to decrease the risk of Clostridium difficile infection (a type of bacteria that can cause severe or life-threatening diarrhea) from coming back in people at high risk for C. difficile infection.

FDA MedWatch Alert Revisions

FDA is warning that eluxadoline (Viberzi®), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder.

1 2 3 4 14