FDA approves dupilumab for children aged 6 to 11 with moderate to severe asthma

Now that another biologic therapy is available for pediatric severe asthma, it is important to look at the indications for add on biologic therapy for asthma.  In general, there are 2 broad categories of asthma that may warrant adding an injectable biologic therapy:

1) Children and adolescents with severe asthma, poorly controlled despite compliance with high dose asthma therapy.  Here, poorly controlled may indicate frequent hospitalization, ER, or urgent care visits.  In addition, systemic steroid use and symptoms that affect quality of life (school, exercise, etc) are important considerations.

2) Children and adolescents with severe asthma that is controlled, but requires high dose asthma controller medication.  This is an important consideration because high dose inhaled glucocorticoids have been associated with a numbers of risks including reduced growth velocity, obesity, adrenal insufficiency, and ocular side effects like cataracts.

The FDA has approved dupilumab as an add-on maintenance treatment for children aged 6 to 11 years with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
The expanded approval of dupilumab (Dupixent, Regeneron/Sanofi) to children aged 6 to 11 was based on data from the phase 3, double-blind, placebo-controlled LIBERTY ASTHMA VOYAGE trial that evaluated efficacy and safety of dupilumab compared with standard care in children with uncontrolled moderate to severe asthma. More than 90% of children in the trial had at least one concurrent type 2 inflammatory condition, according to a company press release.
“I was impressed that dupilumab met not only its primary endpoint of reduction in asthma exacerbations, but also all key secondary endpoints in the pediatric ASTHMA VOYAGE trial,” Leonard B. Bacharier, MD, professor of pediatrics at Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center and principal investigator of the ASTHMA LIBERTY VOYAGE trial, told Healio. “I anticipate that clinicians will begin to include dupilumab in their discussions with families of children with uncontrolled moderate-severe asthma. Many children in this age group continue to experience repeated asthma exacerbations, and experience side effects from frequent courses of systemic corticosteroids. Dupilumab’s demonstrated efficacy in significantly reducing exacerbations will allow such children greater disease control.” 

Read article here.

Welcome Dupixent!

When new anti-asthma biologics come to the door, always give them a welcome seat. Here is an anti- atopic dermatitis monoclonal antibody that also shuts down a key component of the allergy airway inflammation pathway, now a 12 and up asthma therapy.  Dr. Susarla

Dive Brief:

• Sanofi and Regneron have won an expanded U.S. approval for Dupixent in asthma, securing another indication for the biologic drug which the companies are counting on to deliver blockbuster sales. 
• On Friday, the Food and Drug Administration OK'd the drug for moderate-to-severe asthma patients with an eosinophilic phenotype, or with oral corticosteroid-dependent asthma regardless of phenotype, the companies said. The new indication adds to Dupixent's previously approved use for moderate-to-severe atopic dermatitis.
• Clinical results supporting the approval showed Dupixent cut severe asthma attacks by 67% compared to placebo in patients with high eosinophil counts. Among patients with lower levels of the inflammation marker, however, Dupixent did not separate from placebo in statistical comparison. 

Read article here.