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Loading ...Full FDA approval sought for HIV treatment
02.05.2009 3:18pm EST
(Washington) A division of Johnson & Johnson has asked federal regulators to grant full approval to an HIV drug designed to treat patients who have stopped responding to other treatments.
The Food and Drug Administration gave Intelence preliminary approval in January under its accelerated approval program, which allowed J&J to market the drug. In order to gain full approval, FDA required the company to submit follow-up data on the drug’s effectiveness.Data submitted by J&J’s Tibotec unit showed that 60 percent of patients taking the drug for four months had undetectable levels of HIV in their blood compared with 39 percent of patients taking a placebo.
Intelence is a non-nucleoside reverse transcriptase inhibitor, or NNRTI, that blocks the enzyme HIV needs to multiply.
Tibotec Therapeutics is a division of Ortho Biotech Products, L.P., a Johnson & Johnson company based in Bridgewater, N.J.
My roommate was part of the clinical trail for this drug. He has been positive for over 22 years and there were no more cocktails for him. We truly expected to bury him last year.
Within 3 months, his viral load was undetectable for the first time ever and his t-cells are thru the roof! In fact he’s gained so much weight back, they told him to lose 10 pounds! I told him if he dies from being fat, good for him! Eat and be happy! How many times has he looked death in the face and laughed.
I don’t know how the placebos figure into to this, but truly this drug is a God send for people at the end and I sincerely hope that the FDA approves this for the masses. I’ve buried too many friends already.
Tedd – Yeah I noticed that too… says a lot for the “power of positive thinking” or perhaps “positive hoping” at any rate. Still, the more back-up meds that can get approval – the better.
Gosh. The “Placebo Effect” had a 39 percent effectiveness rate. And it doesn’t cost a dime.