Byetta LAR.

Byetta LAR is due to get US approval early next month and should get European approval later in the year.

Though it appears that it will get a new name at launch, though Lily haven't ruled out keeping the name, but suggest it is unlikely.

My god. A once weekly injection? That is awesome.

humph said:

Byetta LAR is due to get US approval early next month and should get European approval later in the year.

Though it appears that it will get a new name at launch, though Lily haven't ruled out keeping the name, but suggest it is unlikely.

Click to expand...

Humph.
Do you have a source for that information. I would be interested to see that.

According to the info on the Stock Market (US) Amylin expects to file for regulatory approval of once weekly Byetta by the end of the second quarter. That is only the first step in getting approval for the issuing of the drug, that could take quite some time as it is a long winded process.

So I wouldn't bank on it being available anytime soon.....!

Ken.

http://online.wsj.com/article/BT-CO-20100126-709340.html

This link states that it is expected March, but some expect delays. I am on a drugs sales rep forum and they are confident they will get approval. I did also find a link were someone from the company said they were confident, but cannot find it at the moment.

The FDA won't want Novo Nordisk getting to great a time advantage over an American product.


http://industry.bnet.com/pharma/100...on-the-byetta-name-for-exenatide-once-weekly/

This article is about the possible name change.

This states expected approval too.

http://www.minyanville.com/articles/print.php?a=26542

Hi Humph.
Thanks for those links, I had seen a couple of them before, unfortunately they are all US info about the drug.

We do not as yet have anything about a UK licence, which first of all has to go through the EMEA, the European Medical Agency. They are the ones who will licence it here and in Europe. Not the FDA.

Do you have anything that actually relates to the release in Europe and more importantly the UK ? We are usually around 12 - 18 months behind what takes place in the States.

Ken.

Byetta LAR or as it is now called Bydureon didn't get FDA approval, but the issues raised were mainly to do with labeling. It looks like no issue with thyroid cancer was raised, unlike the black box labeling requirement with Liraglutide. The FDA have not requested any additional clinical trials.

Approval is now expected within 10 weeks. My Consultant reckons approval here will be quicker than normal because Bydureon is likely to be cheaper than Victoza. Byetta is already cheaper.

Who knows, but Bydureon will likely be a very good addition to the drugs available.