Fasenra

Fasenra receives FDA approval for asthma treatment in children aged 6 to 11 years

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Key takeaways:

  • The approval follows positive results from the TATE trial.
  • A new 10 mg dose will be available to accommodate children who weigh less than 35 kg.

The FDA approved the use of Fasenra for the treatment of severe asthma in children aged 6 to 11 years, AstraZeneca announced in a press release.

Fasenra (benralizumab, AstraZeneca) was first approved in 2017 for additional maintenance treatment of severe eosinophilic asthma in patients aged at least 12 years. The approval for treatment of children aged 6 to 11 years was supported by evidence from the TATE study as well as trials in adult and adolescent populations, according to the release.

little girl getting a shot
Fasenra is administered by subcutaneous injection every 4 weeks for the first 3 doses then once every 8 weeks.

In the TATE study, an open-label, multinational, phase 3 study of benralizumab in children aged 6 to 11 years with severe eosinophilic asthma, results were consistent with previous FASENRA trials in assessing maximum serum concentration, clearance, half-life and blood eosinophil count as well as safety and tolerability.

“These results add to Fasenra’s growing body of evidence, further characterizing its well-established safety profile, and represents a crucial step in offering children with [severe eosinophilic asthma] a wider choice of treatment in the future,” Donna Carstens, MD, senior director, medical affairs, Fasenra, AstraZeneca, told Healio.

Donna Carstens, MD

The recommended dose of Fasenra is 30 mg for patients aged 6 years or older who weigh 35 kg or more. A new 10 mg dose will be available for patients aged 6 to 11 years who weigh less than 35 kg. Fasenra is administered subcutaneously by injection every 4 weeks for the first three doses and then once every 8 weeks.

“Additional treatment options for children living with severe asthma are needed to help address the unmet need in this patient population and to reduce the burden of disease for the broader asthma community,” Carstens said. “The FDA’s decision to expand the approved use of Fasenra for the add-on maintenance treatment of patients aged 6 to 11 years old addresses this unmet need and represents a significant step in offering children with [severe eosinophilic asthma] a wider choice of treatment in the future.”

According to Carstens, the company plans to continue to evaluate Fasenra’s potential to treat different age groups across disease states.

“AstraZeneca’s mission is to revolutionize asthma care for all patient age groups,” she said.