Is dupixent approved for asthma in teenagers?

Is dupixent approved for asthma in teenagers?

Dupixent is approved for moderate to severe asthma in people 12 years and older.

How does the approval age range compare with other biologics for asthma?

Most newer asthma biologics also cover adolescents. Dupixent, Nucala, Fasenra, and Xolair all list use starting at age 12 or younger, while Cinqair remains limited to adults 18 and up.

When did regulators expand the age range to include teenagers?

The FDA first cleared Dupixent for asthma in adults in 2018. The label was broadened to ages 12 and older in 2019 after additional pediatric data were submitted.

What dosing is used in teenagers?

Teens receive the same weight-based dosing as adults: 200 mg every two weeks or 300 mg every two weeks depending on blood eosinophil count and oral-steroid use. Injections are given under the skin.

What side effects are parents most concerned about for teens?

Injection-site reactions and conjunctivitis occur more often than with placebo. Hypersensitivity reactions and rare joint pain have also been reported; monitoring is advised in the first months of treatment.

Are there differences in real-world effectiveness between teens and adults?

Post-marketing registries show similar reductions in exacerbations and oral-steroid use in both age groups, although adherence can be lower among adolescents.

When does the main Dupixent patent expire?

The primary U.S. composition-of-matter patent is scheduled to expire in 2031, with some method-of-use patents extending further. Biosimilar entry is unlikely before that date.