Update on ATX-101 Kythera in US

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Aeronick

Update on ATX-101 Kythera in US

Post by Aeronick » Thu Feb 16, 2012 10:02 am

There seemed to be a promising treatment in my search of the ATX-101 (DC) product Kythera Pharma was testing in the US. After speaking to them today, however, a rep told me that they concluded from the trial 4 years ago that the drug is not effective in treating lipoma - the effect was a reduction but not a significant enough amount to be considered worth passing the procedure of approval

That said, I believe the hope of DC as an FDA regulated treatment has pretty much died. It's a shame really, since reduction is in many cases enough... In any case, I still actively seek a non-surgical treatment for this crazy little tumor that won't wreck my tattoo and leave a scar. I'm somewhat hopefu that cryolipolysis is a future option if the company behind manufacturing the machines can produce a smaller vacuum/cooling head. Emails to coolsculpting producer Zeltiq have yielded only modest returns - our plight doesn't appear a large money maker for them - perhaps letters to them would help!

Nick
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Re: Update on ATX-101 Kythera in US

Post by matt » Thu Feb 16, 2012 11:05 am

Hi Nick,

thanks for sharing although this is not very good news.

There's a study published in Pubmed in 2005 by Dr. Rotunda which states that the mean area reduction of 75% (range, 37%-100%) was achieved with only 2.2 injections for lipomas.

So I'm left puzzling what would be considered as a significant reduction enough for Deoxycholate injection to be passed the procedure of approval? :shock:

I wonder whether this has something to do with the fact that lipomas will recur after the initial injections?

But in any case this if something I would consider significant enough!

Still, Deoxycholate has always been just a treatment option, not a cure. And I'm confident there are more sophisticated ways to treat and cure lipomas.
Hi I'm Matt - the creator and owner of this site. I have dozens of small nasty lipomas all over. I've tried many treatments including surgery and Lipostabil injections. See my lipoma prevention supplement recommendations and please consider donating a small amount via PayPal (click the Donate button) to keep this site up and running. Thx!
Aeronick

Re: Update on ATX-101 Kythera in US

Post by Aeronick » Tue Jun 05, 2012 2:59 pm

Thanks Matt - Now that the trial(s) have ended, I wonder if deoxycholate is being administered professionally in the US?

The cryolipolysis option is really up-and-coming. I'll keep trying to address Zeltiq about options. It's important to note, though, that choosing to do injections is expressly called out as something that would abate treatment by cool sculpting. If one has had injections, doctors would shy away from treatment...

Best
Nick
Still, Deoxycholate has always been just a treatment option, not a cure. And I'm confident there are more sophisticated ways to treat and cure lipomas.
Quinn

Re: Update on ATX-101 Kythera in US

Post by Quinn » Tue Jun 05, 2012 11:25 pm

ATX-101, is currently in Phase III clinical development for the reduction of submental fat---thus, if approved, you might be able to use off-label for lipoma.
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Re: Update on ATX-101 Kythera in US

Post by matt » Sun Jul 08, 2012 4:53 pm

True, unfortunally the 3rd phase is usually the longest and could take still years to accomplish. I'm sorry if I sound pessimistic but I originally was hoping to see this drug in markets in 2007. But hopefully it'll come soon :)
Hi I'm Matt - the creator and owner of this site. I have dozens of small nasty lipomas all over. I've tried many treatments including surgery and Lipostabil injections. See my lipoma prevention supplement recommendations and please consider donating a small amount via PayPal (click the Donate button) to keep this site up and running. Thx!
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Re: Update on ATX-101 Kythera in US

Post by matt » Sun Sep 15, 2013 12:33 am

I found the following post from the lipolysis network site. It's not very new but it seems there's controversy among the medical community whether or whether not the Deoxycholate alone is more efficient.
The main outcome of our survey of the members was, first of all, that the NETWORK very much welcomed the fact that a global player is seeking to register a product that will make the work of the NETWORK-Lipolysis easier in future. There were, however, also doubts among those who responded as to whether deoxycholic acid (DOC) as the sole active ingredient would not act too aggressively on the fatty tissue. Especially Prof. Lukas Prantl of Regensburg University, who has conducted and published studies into the efficacy of desoxycholic acid and the second active substance used in Lipostabil, i.e. polyenylphosphatidylcholine, drew attention to the fact that DOC, a bile acid, is an aggressive substance, and pointing out that in combination with phosphatidylcholine its aggressiveness is toned down; he also remarked that the combination of the two substances together has the further advantage that the fat cells are not just destroyed (lipodestructive effect), but also emptied (lipolytic effect).
However, it is intended to wait for the Phase 3 study to be completed under the licensing procedure and scrutinize the results when they are published. Only then will it be possible to make a final assessment.
Source: http://www.network-lipolysis.com

According to the pipeline pic of the Kythera Biopharmaceuticals the ATX-101 should soon (relative, could still take years) be in market in Europe and Phase 3 results should be available in the mid-2013: http://www.kytherabiopharma.com/pipeline/

Apparently Kythera Biopharmaceuticals is in collaboration with Bayer in Europe.
Hi I'm Matt - the creator and owner of this site. I have dozens of small nasty lipomas all over. I've tried many treatments including surgery and Lipostabil injections. See my lipoma prevention supplement recommendations and please consider donating a small amount via PayPal (click the Donate button) to keep this site up and running. Thx!
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Re: Update on ATX-101 Kythera in US

Post by matt » Tue Oct 15, 2013 2:53 pm

Kythera has published a new press release on Additional Positive Efficacy and Patient Satisfaction Data from ATX-101 Phase III Trials for the Reduction of Submental Fat.

Although this mostly applies to the chin fat reduction it's a good sign to us still. This means people were having few if any side effects from the injections.
Hi I'm Matt - the creator and owner of this site. I have dozens of small nasty lipomas all over. I've tried many treatments including surgery and Lipostabil injections. See my lipoma prevention supplement recommendations and please consider donating a small amount via PayPal (click the Donate button) to keep this site up and running. Thx!
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Re: Update on ATX-101 Kythera in US

Post by matt » Tue May 13, 2014 1:21 pm

Kythera has submitted a new drug application to the FDA concerning the ATX-101.

Although the approval process can take up to a year I think this is good news! The drug is being evaluated for the reduction of unwanted fat under the chin but I'm 100% positive that if approved it'll be available for lipomas off-label.
Hi I'm Matt - the creator and owner of this site. I have dozens of small nasty lipomas all over. I've tried many treatments including surgery and Lipostabil injections. See my lipoma prevention supplement recommendations and please consider donating a small amount via PayPal (click the Donate button) to keep this site up and running. Thx!
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Re: Update on ATX-101 Kythera in US

Post by 251152 » Tue May 20, 2014 1:52 am

Yeah, the news are good!
Now the only thing still remaining as a problem is the price...
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Re: Update on ATX-101 Kythera in US

Post by victor » Fri Aug 22, 2014 8:40 am

Wow... more great news !
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Re: Update on ATX-101 Kythera in US

Post by matt » Tue Mar 10, 2015 3:24 pm

ATX-101 is about to be approved by the FDA in any moment now. The share price of Kythera Biopharmaceuticals rallied already on Monday because of the preliminary approval. ATX-101 will most likely be approved for the treatment supplemental fat under the chin but MDs may describe it for off-label use and for lipomas too.

The cost is not known yet but will likely be a couple of hunreds of dollars per injection/area. So it will not be cheap but at least it's an option. Most likely multiple injection will be needed and recurrence may happen of lipomas. So repeated injections would be necessary.

This is the second time lipoma sufferers might have an approved treatment available. First time was the short period before Lipostabil (aka LipoDissolve) was banned. One of the key compounds in Lipostabil was Deoxycholine, the single active ingredient in ATX-101.
Hi I'm Matt - the creator and owner of this site. I have dozens of small nasty lipomas all over. I've tried many treatments including surgery and Lipostabil injections. See my lipoma prevention supplement recommendations and please consider donating a small amount via PayPal (click the Donate button) to keep this site up and running. Thx!
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Re: Update on ATX-101 Kythera in US

Post by matt » Fri Mar 13, 2015 9:05 am

Westlake Village, Calif., March 9, 2015 – KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) announced today that the U.S. Food and Drug Administration’s (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support the approval of ATX-101 (deoxycholic acid) injection for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults, which is often referred to as a double chin. If approved, ATX-101 would be a first-in-class submental contouring injectable drug.

“We are pleased that the FDA advisory committee recognized the importance of providing patients with a clinically-proven treatment option specifically developed to contour submental fullness, a much-cited yet undertreated facial aesthetic complaint,” said Frederick C. Beddingfield, III, M.D., Ph.D., chief medical officer, KYTHERA Biopharmaceuticals. “We look forward to working with the FDA as they continue their review of ATX-101 with the goal of providing patients with the first and only approved non-surgical treatment for submental fullness.”

The committee’s recommendation, although not binding, will be considered by the FDA as it continues its review of ATX-101. If approved by the FDA, KYTHERA anticipates launching ATX-101 in the second half of 2015.

“This milestone demonstrates our commitment to developing first-in-class aesthetic products through a focus on scientific rigor and innovation,” said Keith Leonard, president and CEO, KYTHERA Biopharmaceuticals. “At KYTHERA, we remain focused on investing in novel treatments that will allow aesthetic physicians to better meet the needs of their patients.”
Source
Hi I'm Matt - the creator and owner of this site. I have dozens of small nasty lipomas all over. I've tried many treatments including surgery and Lipostabil injections. See my lipoma prevention supplement recommendations and please consider donating a small amount via PayPal (click the Donate button) to keep this site up and running. Thx!
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Re: Update on ATX-101 Kythera in US

Post by matt » Sat Oct 03, 2015 11:24 pm

FDA has approved ATX-101, more here: http://www.kythera.com/products/atx-101/


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Hi I'm Matt - the creator and owner of this site. I have dozens of small nasty lipomas all over. I've tried many treatments including surgery and Lipostabil injections. See my lipoma prevention supplement recommendations and please consider donating a small amount via PayPal (click the Donate button) to keep this site up and running. Thx!
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