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TMC125: Tick, Tock, Tick, Tock

Posted on January 18th, 2008 by Joanna Breitstein

If you follow any news from the HIV/AIDS market at all, no doubt you’re like us—waiting on pins and needles to hear if FDA will approve Tibotec’s non-nucleoside reverse transcriptase inhibitor, TMC125.

The drug was accepted for priority review by FDA, with a PDUFA date of today. I got tired of checking the company’s Web site every five minutes, so I rang them—but still no word.

“Having been through this process many times, I can tell you, we probably won’t hear until late in the day,” said a spokesperson for the company. But there’s a lot of excitement inside the company, and the PR department has been busy working on press materials all day.

If you’ll recall, Pharm Exec reported on the company’s promising treatment back in August. (Click here to read that story.) TMC125 is a highly anticipated AIDS treatment. The company received rave reviews for working closely with the HIV community in developing the drug.

For more information about TMC125, click here. In the meantime, I hope to hear from the hard-working folks at FDA soon. Check back here for updates.

UPDATE: TMC125 received FDA approval. It is the first NNRTI to work in patients who have resistance to other NNRTIs and ARV agents. Its marketed name is Intelence, and the Web site for both patients and providers is here.

Tags: Regulatory

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