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Novartis Gets FDA Green Light To Treat Teen Skin Condition With Cosentyx

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The FDA has approved Novartis' Cosentyx for adolescents with a painful inflammatory skin disease, expanding the drug's reach into a younger patient population with limited treatment options.

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Here's some good news for younger patients dealing with a tough skin condition: the U.S. Food and Drug Administration just gave Novartis AG (NVS) the go-ahead to use its drug Cosentyx for kids.

Specifically, the approval covers pediatric patients 12 years and older who have moderate to severe hidradenitis suppurativa, or HS. If you're not familiar, HS is a chronic, systemic inflammatory skin disease. It causes recurring boil-like lesions that can rupture into painful wounds and lead to scarring. It's not rare—it affects as many as 1 in 100 people worldwide—and it often starts making life difficult right around puberty.

"With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust," said Victor Bultó, President of Novartis US. "Yet for young people living with moderate to severe hidradenitis suppurativa (HS), treatment options have remained limited for far too long. Expanding Cosentyx to this population addresses a critical gap in care and underscores our focus on advancing solutions where we can make the greatest impact on outcomes."

This isn't Cosentyx's first rodeo with younger patients. The approval actually marks the drug's fourth pediatric indication, which adds to its track record on safety and efficacy. The FDA's decision was backed by studies and pharmacokinetic modeling that support using Cosentyx in patients aged 12 and up who weigh at least 30 kilograms. Researchers didn't start from scratch; they extrapolated this modeling from adult HS and psoriasis clinical trials, plus pediatric clinical trial data from other approved uses of the drug.

The dosing analysis also played a key role. It predicts that weight-based dosing for pediatric patients can provide drug exposure similar to what adult HS patients receive, which helps bridge the data gap.

On the market side, Novartis shares were trading higher by 0.96% at $154.92 at the time of the original report.

Novartis Gets FDA Green Light To Treat Teen Skin Condition With Cosentyx

MarketDash
The FDA has approved Novartis' Cosentyx for adolescents with a painful inflammatory skin disease, expanding the drug's reach into a younger patient population with limited treatment options.

Get Novartis AG Alerts

Weekly insights + SMS alerts

Here's some good news for younger patients dealing with a tough skin condition: the U.S. Food and Drug Administration just gave Novartis AG (NVS) the go-ahead to use its drug Cosentyx for kids.

Specifically, the approval covers pediatric patients 12 years and older who have moderate to severe hidradenitis suppurativa, or HS. If you're not familiar, HS is a chronic, systemic inflammatory skin disease. It causes recurring boil-like lesions that can rupture into painful wounds and lead to scarring. It's not rare—it affects as many as 1 in 100 people worldwide—and it often starts making life difficult right around puberty.

"With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust," said Victor Bultó, President of Novartis US. "Yet for young people living with moderate to severe hidradenitis suppurativa (HS), treatment options have remained limited for far too long. Expanding Cosentyx to this population addresses a critical gap in care and underscores our focus on advancing solutions where we can make the greatest impact on outcomes."

This isn't Cosentyx's first rodeo with younger patients. The approval actually marks the drug's fourth pediatric indication, which adds to its track record on safety and efficacy. The FDA's decision was backed by studies and pharmacokinetic modeling that support using Cosentyx in patients aged 12 and up who weigh at least 30 kilograms. Researchers didn't start from scratch; they extrapolated this modeling from adult HS and psoriasis clinical trials, plus pediatric clinical trial data from other approved uses of the drug.

The dosing analysis also played a key role. It predicts that weight-based dosing for pediatric patients can provide drug exposure similar to what adult HS patients receive, which helps bridge the data gap.

On the market side, Novartis shares were trading higher by 0.96% at $154.92 at the time of the original report.