FDA Expert Panel Says Yes to Liraglutide for Obesity

Yes is the word from an FDA expert panel that today considered liraglutide 3mg for treating obesity. The Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 that the risk/benefit profile was favorable.

Efficacy data for liraglutide was not really up for much debate. FDA statistician Bradley McEvoy raised a methodological issue with the way that missing data was handled. He started by saying that FDA was not questioning that efficacy had been demonstrated for liraglutide. But he went on to take issue with details of how missing data were handled in the efficacy analysis by Novo Nordisk. So the panel received a tutorial on analytical methods.

Other than that one little untidy portion of the hearing everything else was very orderly. A total of 21 heath advocates testified in the open public hearing, with all but two urging the panel to consider the need for more options to treat obesity. Speaking for the Obesity Action Coalition, CEO Joe Nadglowski said:

Untreated obesity has serious consequences that go well beyond cardiometabolic risk. FDA has received sufficient data to allow patients and their doctors to weigh the risks and benefits of treatment.

Speaking for the Obesity Society and the Obesity Care Continuum, Domenica Rubino said:

Today, we, the OCC, strongly encourage the FDA to continue to be proactive in its evaluation of both the risks and benefits of liraglutide. For the first time in history, we are glimpsing an emerging spectrum of tools to treat a person with obesity. It is imperative that we keep this positive energy in our move forward with the future approval of obesity treatment options to improve the feeling, form and function of those who suffer from obesity and its complications.

The testimony of at least nine people personally affected by obesity was particularly moving. Dan Wright spoke eloquently when he said:

I was a big bundle of cardiac risk factors before I found effective treatment, like all of my family before me. Now I am no longer that bundle of risk factors. I urge this committee to reject the thinking of society that blames people with obesity for their risk factors.

This hearing was day and night different from hearings just four years ago that were evidently biased against any treatment for obesity. Back then, Morgan Downey observed, “water would not be safe enough to pass one of these panels.”

Progress is sweet.

Click here to read more from Reuters.

Yes! photograph © Joe Shlabotnik / flickr

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