Some asthma patients need more than just an inhaler. That’s why the US Food and Drug Administration (FDA) approved the medication Dupixent, an injectable biologic that promises to help patients who might not be able to control their severe asthma attacks with current medications.
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According to a statement issued by drug manufacturer Regeneron Pharmaceuticals, Dupixent is an add-on maintenance therapy. This means that it should be used in conjunction with other asthma medicines. The drug was approved for patients who suffer from eosinophilic phenotype or oral corticosteroid-dependent asthma and are aged 12 years and older.
“Despite the spectrum of treatments for asthma, there continues to be an unmet need for so many patients with moderate-to-severe asthma, and given that Dupixent works differently than other biologics, there is now a new treatment option for some of these patients,” said Olivier Brandicourt, MD, Chief Executive Officer of Sanofi.
The drug comes in pre-filled syringes and is intended for injection under the skin by a healthcare provider, but it can also be administered by the patient at home after training by a healthcare professional.
While helping patients improve their breathing, Dupixent may also help reduce the amount of oral corticosteroids they need to prevent asthma attacks.
The drug functions by inhibiting the overactive signaling of two key proteins, interleukin-4 (IL-4) and interleukin-13 (IL-13), that contribute to the inflammation that may cause asthma.
The efficacy and safety of Dupixent was demonstrated in results from a clinical trial program that evaluated 2,888 adult and adolescent asthma patients in three randomized, placebo-controlled, trials for six months to one year. Data from the trails was published in The Lancet in April 2016 and in the New England Journal of Medicine in May 2018.
In the largest trial, Dupixent showed statistically significant and clinically meaningful improvements in lung function. Asthma symptoms decreased in patients with eosinophil counts, a type of white blood cell, greater than or equal to 150 cells/microliter, which represented 70% of those who were enrolled. Efficacy improved in patients with higher eosinophil counts.
In another trial, which evaluated severe, oral corticosteroid-dependent patients, Dupixent reduced average daily oral corticosteroid use by 70% compared to 42% with a placebo. More than half of patients treated with Dupixent completely eliminated use of oral corticosteroids.
“Despite being compliant with their current medicine, many people with moderate-to-severe asthma, including those with eosinophilic phenotype or with oral steroid dependence, live with persistent symptoms like unpredictable attacks and difficulty breathing,” said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA). “AAFA supports the availability of innovative new treatment options for people with asthma who struggle with uncontrolled symptoms that impair their quality of life.”