The Bubble Boy

Stealth FDA Approval: Semaglutide for Teens

Very quietly, just before Christmas, FDA approved a major step forward for treating obesity in teens. The agency issued an approval for Wegovy brand of semaglutide to treat obesity in teens. There was no press release at FDA, none on the corporate website for Novo Nordisk. As late as yesterday, the news of this approval could only be found on the U.S. website for the company. It was stealthy news release.

A Stealthy Big Deal

Really, it’s fine not to have the PR machine pumping out sensational headlines about this very important news. Headline writers haven’t done so well lately with stories about big news of breakthroughs in treating obesity. As if to prove our point, the Daily Mail published a story late yesterday, with a headline describing Wegovy in terms of magic:

Weight loss ‘magic bullet’ Wegovy approved by FDA for children as young as 12

Nope, this is not magic. It’s advanced medicine. It is simply more effective than any medicine that pediatricians have ever had to offer for their patients down to the age of 12. Like any prescription drug it’s not something to trivialize because it can have side effects and doctors need to monitor its use with care.

Outstanding Effectiveness

Claudia Fox, co-director of the Center for Pediatric Medicine at the University of Minnesota, described the importance of the efficacy that semaglutide brings to adolescent medicine:

“These results [with semaglutide] are mind-blowing in summary. I think we really are at the doorstep of a new era in terms of how we are now going to be able to really effectively treat adolescent and pediatric patients with obesity.”

Professor Sarah Armstrong added perspective to the clinical trial results in a panel discussion at ObesityWeek, saying:

“I do want us all to think about what’s next. After we’ve really helped them in such a profound way, how can we help support them?”

She is precisely right. The approval of semaglutide for treating obesity in youth down to the age of 12 is great news. But it will be essential to build upon that approval with systems of care that deliver good outcomes over the long term.

As people who care about the health of our children, we all have a lot of work to do. The semaglutide approval for teens is a big advance, but it’s not a “magic bullet.”

Click here for the quiet news release from Novo Nordisk, here for the approval letter from FDA, and here for the revised prescribing information. For further reporting on this news, click here.

The Bubble Boy, painting by Paul Peel / WikiArt

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December 29, 2022