On Tuesday, March 28th, the FDA announced the approval of Dupixent (dupilumab), an injection for the treatment of adults with moderate-to-severe atopic dermatitis.
What is Atopic Dermatitis?
Atopic dermatitis is a chronic inflammatory skin disease that “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 form of eczema. It is most prevalent in children, but can last through adulthood and can occur at any age. The condition is caused by a combination of genetic, immune, and environmental factors, and affects the skin’s ability to hold moisture.
Symptoms of Eczema
“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,” states a recent press release from the FDA. Additionally, people who suffer from eczema are more also likely to develop asthma and/or seasonal allergies.
From simple lotions to steroid creams and immune suppressant drugs, there are a variety of products on the market that are used to treat eczema. However, none of these treatments work for everyone suffering from the condition, “and the immune suppressant drugs can raise the risk of cancers such as lymphoma,” claims a recent article from NBC News. As such, eczema and its treatment has been an ongoing struggle for many suffering from the uncomfortable condition.
FDA-Approval of Dupixent
Last month the Agency approved Dupixent, providing patients with a solution to the ongoing battle with the unpleasant skin condition. Dupixent is manufactured by Regeneron Pharmaceuticals, Inc., and was approved via the FDA’s Priority Review and Breakthrough Therapy designation.
Dupixent is administered twice-a-month as an injection under the skin. The product can be used with or without topical corticosteroids, and is intended for serious cases of eczema in which topical therapies have not helped, or situations where topical therapies are not advisable.
The injection’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.”
Safety & Efficacy of Dupixent
Regeneron established the safety and efficacy of Dupixent in three placebo-controlled clinical trials, in which there were 2,119 adult participants suffering from moderate-to-severe atopic dermatitis that was not being 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.”
Although many patients with eczema also suffer from allergies and asthma, the FDA draws attention to the fact that the product has not been approved for the treatment of asthma. As such, the Agency states that individuals should not adjust or stop their asthma treatment without speaking to their physician.
Side Effects of Dupixent
The most common side effects associated with the use of Dupixent include:
- Injection site reactions
- Cold sores in the mouth or on the lips
- Eye and eyelid inflammation (redness, swelling, and itching)
Some more serious side effects can include serious allergic reactions and eye problems, including pink eye (conjunctivitis) and inflammation of the cornea (keratitis). Patients are advised to contact their health care provider if they “experience new or worsening eye symptoms such as redness, itching, pain or visual changes.”
FDA’s Commitment to Approving New & Innovative Therapies
In the Agency’s press release, Julie Beitz, MD, Director of the Office of Drug Evaluation III, stated that this approval demonstrates the FDA’s “commitment to approving new and innovative therapies for patients with skin disease. 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.”
The approval of a new treatment for eczema will fill a huge unmet need that will help thousands of people suffering from the skin condition. However, there are still a plethora of conditions without any known or approved treatments. In an effort to get new and innovative therapies on the market, FDA may expedite the approval process for products that are indicated for these conditions. Developing these products is a very challenging task, and getting them approved by the Agency can be just a difficult. That is why we are here to help.