Isentress Approval Expected by Mid October

[RAB]

Hello everyone:

I'm not sure where to post this.  I got this information regarding Merck's new inhibitor yesterday from one of my "salvage therapy" groups.

Looks like the drug will be available around mid October.  For those of us using Fuzeon and wanting to change, this is good news.



Wed Jun 27, 2007 1:25PM EDT
NEW YORK (Reuters Health) - U.S. regulators will review Isentress, an investigational drug for HIV infection, on a priority basis, and a decision is anticipated by mid-October, Merck & Co. said on Wednesday.

The oral drug is the first in an HIV drug class called integrase inhibitors. It is generically known as raltegravir, and formerly known as MK-0518. The drug blocks the insertion of HIV's genetic material into human DNA and thereby prevents the virus from replicating. It should be taken twice daily, and can be taken with or without food.

The preliminary results of two phase III trials, presented earlier this year at 14th Annual Retroviral Conference, showed that raltegravir is active against HIV in patients resistant to all three previously approved drug classes for HIV infection.

Merck said the drug, if approved, will be used alongside standard oral HIV drugs by patients who are no longer adequately protected by their current treatments because of viral resistance.

The agency grants priority review to products that are considered to be potentially significant therapeutic advancements over existing therapies.

With priority review status, the U.S. Food and Drug Administration will make its decision on whether to approve the drug within 6 months, rather than the usual 10- to 12-month review period.

Merck tested Isentress in patients who continued to take a standard HIV drug regimen, although they were infected with strains of the virus that had become resistant to at least one drug in each drug class.

Merck added that it is also moving forward with marketing applications for the drug outside of the United States

[allanq]

I've mentioned this in other threads, but this looks like a good place to say it again.

I was able to go off Fuzeon in March and start Isentress. It's made a huge improvement in my quality of life. One purple pill twice a day, with or without food. No more painful injection site reactions!

The Isentress has been effective in keeping my viral load undetectable, and I haven't experienced any side effects.

Allan

[milker]

great news !!!

[J220]

I've mentioned this in other threads, but this looks like a good place to say it again.

I was able to go off Fuzeon in March and start Isentress. It's made a huge improvement in my quality of life. One purple pill twice a day, with or without food. No more painful injection site reactions!

The Isentress has been effective in keeping my viral load undetectable, and I haven't experienced any side effects.

Allan

That's great news. Just curious, are you taking other medications as well, or just the Isenstress? J.

[J220]

If all goes well, 2007 may turn out to be yet another great year in the fight against hiv, with these new classes of medications! Onward! J.

[allanq]

J220,

In addition to the Isentress I take Prezista/Norvir and Sustiva.

No one should take Isentress (or any other HIV drug) alone.

Allan

[Miss Philicia]

As I stated in a thread last week, once approved I'll be switching from Fuzeon to Isentress.  That will be 1.5 years on Fuzeon and while I've handled it OK, including quite a bit of traveling while on it, inevitably there's about 5 days/month where I'm just over it.

I was just told by my doctor to expect September, so whatever information he was going on that's already been outdated in the past week.  And of course, the key word is still "anticipated" -- if you didn't read the 6/20 piece by Tim Horn in poz.com Maraviroc is having some delay.