FDA Approves New Merck HIV Medication

J0321082Yesterday the FDA announced a new drug approval for the treatment of HIV.   Bucking the FDA’s recent inclination to approvable letters, the approval of Isentress (raltegravir) brings a first-in-class treatment known as integrase strand transfer inhibitors to the armentarium of HIV medications.   Isentress, manufactured by Merck,  had a priority review by FDA, meaning that the PDUFA date was set for 6 months after NDA filing, rather than the traditional 10 months.  Isentress (odd name) is indicated for combination use with other antiretroviral agents in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

A first-in-class announcement is always an important milestone.  But this one is noteworthy to me when I put it in perspective of the history of HIV treatment.  The first protease inhibitor, Saquinivir by Roche was approved by the FDA in December, 1995.    For those of us who were stakeholders in the issue, that was an exciting time.  People with AIDS and their caregivers had waited for a very long time for a medication that would actually make a difference in the staggering suffering experienced during the years that had passed since 1981.   The following year after Saquinivir’s approval, I can still remember David Ho, who became TIME Magazine’s Man of the Year, speaking at the International AIDS Conference in Vancouver and uttering the words "eradication of the virus" and raising the possibility, to a hushed auditorium of hundreds of people – a notion that would have been laughable at the last AIDS gathering. 

But this year, 2007, marks the ten year anniversary that protease inhibitors so dramatically affected the mortality rate of AIDS/HIV.  It was in 1997 that the CDC announced a drop in mortality due to the widespread use of anti-viral therapy.   And this month, a study revealed that mortality among people with HIV continues to decline, though at a slower pace than in previous years. 

And twenty years ago in August 1987, Newsweek published a cover story called The Face of AIDS, publishing pictures of many who had died that year, one of whom was my partner Joe who died in June of that year.  It was an article about mourning and loss.  Today, if they recreated the issue, The Face of AIDS would be different.  It would be stories of people who, rather than die a horrible death in 1997, went on living.  They got married – they earned college degrees, they grew up from a childhood they weren’t expected to survive.  They had children – children who were HIV-negative.  They lived.

I think it important, every so often, to look back and remember what it was like before.  My congratulations to Merck and to all the companies that, together, stopped the slaughter. 

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One Response to FDA Approves New Merck HIV Medication

  1. Devonny says:

    This is such an important development in medicine. What with stem cell research halted (thank you, Bush), any medical advancements are welcome, especially those that save lives. With this medicine, even more people will be saved from death due to HIV/AIDS. Not only will the pill repress symptoms, it will help prevent babies of HIV infected parents from passing the gene on.
    Not only will this drug help patients, it may possibly help the stick market. Stocks for this drug will soar the minute it is on the market; this is a life-preserving drug – its bonds will be highly desired.
    Brilliantly played.