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New Drugs for Cystic Fibrosis – inhalable aztreonam lysine


New Drugs for Cystic Fibrosis – inhalable aztreonam lysine

A Gilead Sciences Inc. investigational antibiotic for cystic fibrosis patients with deadly infections will be reviewed by an FDA panel Dec. 10.

The Foster City-based drug developer (NASDAQ: GILD) said that inhalable aztreonam lysine would be reviewed by the Food and Drug Administration’s Anti-Infective Drugs Advisory Committee. The drug is an antibiotic against the bacteria Pseudomonas aeruginosa, the single greatest cause of death for cystic fibrosis patients.

FDA reviewers in September 2008 recommended that the agency not approve the drug, saying that Gilead needed to do more clinical testing. Gilead last week said that a head-to-head study of the drug versus Novartis AG’s tobramycin inhalation solution, or TOBI, will be fully enrolled by the end of this year and data from the study will be available in mid-2010.

Inhalable aztreonam lysine has won conditional approval in Canada and, in September, Europe under the trade name Cayston. The product will be available in Germany and the United Kingdom in early 2010, Gilead has said.

Gilead also is seeking approval from drug regulators in Australia, Switzerland and Turkey.

The drug has “orphan” status in the United States and Europe, granted to products that treat disorders that affect less than 200,000 people. The designation gives the product seven years of market exclusivity and possible tax breaks while under development.

Source – http://sanfrancisco.bizjournals.com/sanfrancisco/stories/2009/10/26/daily31.html

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Injection solution I use in Nebuliser

PeGsOn’s Response

So I have been using typical Aztreonam for Injection in the my nebuliser for about 18 months now on and off, interchanging between Aztreonam and Coliston as the drug on choice during the month between tobi doeses…So I guess this Azstreonam they are testing ( aztreonam lysine ) and waiting for approval is a sepcialised form of Aztreonam directed at being most suited for the Lung..

I remember when Coliston went through this stage I was using the typical Coliston for injection in my nebuliser before they bought out Colistimethate which I believe is called Tadim here in Australia and the main differences I felt was how much easier it was to breath the stuff.
I Personally find the Azstreonam for Injection slightly difficult to breath and I feel very tight in the chest for quite sometime afterwards which I a huge downside because you almost feel worst during the short term by taking the stuff…So I’m personally hoping the new Specialised Nebulised Solution Astreonam lysine is much easier on the lungs..as for the Lysine word I believe it is an α-amino acid that when used in cancer treatment has the ability destroy cancer cells but leaving healthy cells alone..But like I said I’m not exactly sure what its use with cystic fibrosis is.

As for infectiveness like I said I can only speak for the Azstreonam for injection done via nebulised…I would put it below coliston and Tobi in treating MY exacerbations but its much easier to breath than all forms of Coliston but Tobi in all forms still takes the prize for me…

If you have tried the new drugs send me a comment or email…Its great to see a few new drugs come out helping Cystic Fibrosis over the last few years…We need more..

As for the moment this is a wait and see…

LEAVE COMMENT

PeGsOn

pegson1986@hotmail.com

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October 27, 2009 - Posted by | All Posts, Treatments | , , ,

2 Comments »

  1. I’m like you peg I used the injection solution. i like it for a change. but your right its hard to get down.

    Comment by aaron jerlin | October 27, 2009 | Reply

  2. Hi, very interesting post. Hoping, we’ll be able to work together sometimes..

    Comment by Azizah | June 7, 2010 | Reply


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