Just saw a news article that the FDA may be close to an approval for Coartem (called Riamet in Europe). This is a combination pill of a synthetic artemisinin and lumefantrine developed for malaria. It has been available in approximately 80 other countries, but not the US.
Anyone out there with experience/knowledge of this drug in babesiosis? Anyone know of cures using it?
UPDATED INFO AS OF DEC 3, 4:30 PM == FDA ADVISORY PANEL HAS GIVEN THIS DRUG A THUMBS UP FOR USE IN THE USA. The FDA "powers-that-be" must now decide on final approval for sale.
[ 03. December 2008, 04:28 PM: Message edited by: Lymepool ]
Posted by cactus (Member # 7347) on :
Did the article say how close they are to making it available here?
I've heard good reports about it.
Would love to have it available as an option here.
Posted by Lymepool (Member # 15827) on :
FDA has placed Riamet/Coartem on the expedited review track. The FDA Advisory Committee is meeting today (12/3) to review the data and vote on the drug. The news reports state that the FDA has already published favorable info its website. (I was unable to find the report in a quick search.)
If the Advisory Committee gives it a thumbs up, approval could be as early as year's end. However, I haven't seen anything from the company (Novartis) as to when the drug would actually be available at our local pharmacies. If the drug is approved, I would think that Novartis will issue a press release containing the info. Stay turned.
If you do a search for Novartis on the Yahoo!News page, you will see links to several articles. I will certainly post if I see any interesting info on this.
Posted by Lymepool (Member # 15827) on :
UPDATED INFO AS OF DEC 3, 4:30 PM == FDA ADVISORY PANEL HAS GIVEN THIS DRUG A THUMBS UP FOR USE IN THE USA. The FDA "powers-that-be" must now decide on final approval for sale.
News article indicated that final approval would happen by year's end. The reasoning: while there aren't that many cases of malaria in the USA, many of us travel to areas where malaria is a problem and may contract it while overseas. This drug is seen as very effective against resistant strains of malaria.
Posted by mjbucuk (Member # 843) on :
Anyone venture to guess if this would work for B. duncani?
Posted by seekhelp (Member # 15067) on :
That is excellent news!!
quote:Originally posted by Lymepool: UPDATED INFO AS OF DEC 3, 4:30 PM == FDA ADVISORY PANEL HAS GIVEN THIS DRUG A THUMBS UP FOR USE IN THE USA. The FDA "powers-that-be" must now decide on final approval for sale.
News article indicated that final approval would happen by year's end. The reasoning: while there aren't that many cases of malaria in the USA, many of us travel to areas where malaria is a problem and may contract it while overseas. This drug is seen as very effective against resistant strains of malaria.
Posted by SForsgren (Member # 7686) on :
NutraMedix Enula + NutraMedix Mora seem to work well.
Posted by Rianna (Member # 11038) on :
I am unsure if you are allowed to import this drug? but the following online UK pharmacy sell www.stratford-pharmacy.co.uk and all other Anti Malaria drugs, if its not listed you just emeil them.
They are a real pharmacy that we use here in the UK for Malarone etc.
I've never inserted a link in a post before, so I hope it works.
There may be limits on this in your particular state. Try searching for info on your state government's website. - Lymepool
Posted by Lymetoo (Member # 743) on :
Glad it's being approved!
Posted by mjbucuk (Member # 843) on :
any more recent info??
Posted by Leelee (Member # 19112) on :
Do you think LLMD's will be "legally" allowed to prescribe it for babesia instead of malaria?
It is good news, but I so leery of just about everything any more.
Thanks for sharing.
Posted by tickbattler (Member # 14873) on :
Leelee, it's my understanding that once the drug is approved for one use, MD's can prescribe it for another use under the "practice of medicine" rationale. The FDA does not interfere with doc's practicing medicine in this way.
tickbattler
Posted by Lymepool (Member # 15827) on :
Greetings!
I've been watching the FDA and Novartis websites looking for some news that this has been fully approved. No news as yet.
Leelee, I think Riamet may wind up in the same category as Malarone. Based on what I've experienced, the LLMD might prescribe it, but the drug is only approved for treatment of malaria. The insurance companies may then deny reimbursement for the "off label" use of the drug. The patient, with a prescription, may be able to buy it out-of-pocket.
I will keep looking for signs that Riamet/Coartem has been approved for use in the US and will post as soon as I see something. I am really hoping we get this option.
Best Wishes to all of you in the babesia battle!
Posted by seibertneurolyme (Member # 6416) on :
tickbattler,
Yes MD's can prescribe many meds for off-label use. But look at what happened with quinine. Now that generic is no longer available and only brand name the price is higher and as LymePool states many insurance companies probably would not pay for it to be used for babesia.
Forget which drug company developed the new med for restless legs that led to the ban on generic quinine.