Powerful New Eczema Drug Approved by FDA

The United States Food and Drug Administration (FDA) has recently approved Dupilumab injection for the treatment of moderate-to-severe eczema. Eczema or dermatitis is a condition that causes skin inflammation and swelling. It may also lead to dry, itchy skin and rashes in the face, on the insides of elbows, and behind the knees.

The FDA has granted Break through Designation approval to the Dupilumab drug, which means the drug is capable of treating a serious health condition. Preliminary clinical evidence has proved that the drug is capable of showing significant improvement when compared to the available therapies.

Dupilumab drug is intended to be used for patients whose eczema is not controlled by any topical therapies or specifically in patients for whom the topical therapies are not advisable. Dupilumab drug is an antibody and the active ingredient of the injection Dupixent that has currently been approved.

The drug can be used either with or without topical corticosteroids.

Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said, “FDA’s approval of Dupixent demonstrates our 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.”

Testing the Efficacy of Dupilumab Drug

The efficacy and the safety of Dupilumab drug were studied by carrying out three placebo-controlled clinical trials. About 2,119 people with atopic dermatitis (a common type of eczema), who did not respond properly to topical medications, were considered for the trials.

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The findings revealed that people who received Dupilumab drug had a clear or almost clear skin. These people also had a reduction in skin itching after 16 weeks of treatment.

Dupilumab drug showed a greater response rate when compared to the placebo control in the trials.

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While the safety and efficacy of Dupilumab drug were not well-known in the treatment of asthma patients. It is to be noted that asthma patients must not stop or adjust their medication dose without consulting their physicians.

Dupilumab Drug

Dupilumab drug is an antibody that is available under the brand name Dupixent. It is administered in the form of an injection under the skin.

The drug is capable of binding to a protein (interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra)) which causes inflammation. It mainly acts by binding to the protein and inhibiting the inflammatory response.

Some of the common side effects of the drug include

• Injection site reactions
• Cold sores in the mouth and lips
• Inflammation in the eyes
• Redness or swelling of the skin
• Skin itching

Dupilumab drug may also result in serious allergic reactions which could lead to pink eye (conjunctivitis) or inflammation of the cornea (keratitis). Patients are immediately advised to consult a doctor if they experience any redness, itching or visual changes.

What is Eczema?

Eczema is a condition that causes skin inflammation. Atopic dermatitis is a chronic skin inflammatory disease and is the most common form of eczema. It can be caused by a combination of genetic, immune or environmental factors.

Symptoms of Eczema

• Dry or sensitive skin
• Skin itching
• Areas of swelling
• Scaly patches of the skin
• Oozing of fluids
• Crusty, thickened skin

Interesting Facts on Eczema

• Parents who have allergies, asthma or eczema are more likely to influence or pass on eczema to their children.
• Eczema is more prevalent among people who live in colder climates.
• Dairy products, nuts, shellfish may sometimes be the cause for severe eczema.
• There is no definite cure for eczema. However, treatment options may provide relief from symptoms.

References:

1. FDA approves new eczema drug Dupixent - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549078.htm)
2. FDA approves new eczema drug Dupixent - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549078.htm)
3. Eczema - (https://medlineplus.gov/eczema.html)
4. 5 Interesting Facts About Eczema - (http://healthresearchfunding.org/5-interesting-facts-eczema/)

Source-Medindia