The European Medicines Agency (EMA) has recommended extending the use of Ofev (nintedanib) to include treating progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents aged 6 years or older.
Varying Ofev’s marketing authorization would mark the first approved therapy in Europe for these respiratory conditions in children.
Fibrosing ILDs encompass a group of complex and heterogeneous rare respiratory disorders. They are characterized by scar tissue build-up in the lungs, leading to progressive breathing difficulties. Causes may include autoimmune conditions such as systemic sclerosis.
Ofev is already approved in the European Union for treating fibrosing ILDs in adults. Its active ingredient, nintedanib, blocks the activity of tyrosine kinases, which are involved in scar tissue formation. By inhibiting these enzymes, the drug reduces lung scarring and slows disease progression.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended expanding the drug’s indication to children and adolescents aged 6-17 years for the treatment of clinically significant progressive fibrosing ILDs.
Pediatric Trial Findings
The decision was based on a small pediatric clinical trial and data extrapolated from adult studies. The pediatric trial involved 39 children in a randomized, double-blind, placebo-controlled study, followed by a second study of 33 original participants and 15 new enrollees. Participants were monitored for up to 124 weeks.
The safety profile in children was comparable with that observed in adults. However, potential long-term effects on growth and tooth development were noted. Children receiving Ofev should therefore undergo regular bone imaging and dental exams to monitor these risks, the committee stated. These potential effects will be a focus when additional data is collected after authorization.
A lower-strength version of Ofev capsules will be made available for pediatric use. The medicine is taken twice daily.
The EMA advised that treatment decisions should involve a multidisciplinary team that includes specialists experienced in diagnosing and managing fibrosing ILDs.
The CHMP has submitted its opinion to the European Commission for final approval. If granted, individual EU member countries will decide on pricing and reimbursement in line with their national healthcare systems.
Peter Russell has been a journalist for 40 years covering international news, health, medicine, and national politics on radio, TV, and online. He is based in the UK.
Source link : https://www.medscape.com/viewarticle/ema-supports-expanding-use-ofev-pediatric-ilds-2024a1000n4p?src=rss
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Publish date : 2024-12-13 16:19:52
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