FDA Grants ‘Fast-Track’ Status to Tanox Experimental Viral Entry Inhibitor
The FDA has granted "fast-track" status to an experimental antiretroviral drug being tested by Houston-based drug maker Tanox, the Houston Chronicle reports. Under the hastened review process, the company can submit to the FDA data from clinical trials of the drug as soon as they are available; normally, the agency does not review data until all clinical trials are complete and study endpoints are analyzed, which can take months, according to the Chronicle. When a drug has the potential to treat patients with serious or life-threatening conditions, the FDA can accelerate the review process, although the fast-track designation is not a guarantee that the drug will be approved. Tanox's drug, called TNX-355, belongs to a new class of antiretroviral drugs called viral entry inhibitors, which are designed to prevent HIV from entering immune system cells. The drug could be used to treat HIV-positive patients who have developed resistance to other available treatments. Tanox, which holds exclusive rights to the drug through a license with Biogen, expects to begin Phase II testing of TNX-355 in the first half of 2004, company spokesperson Michelle DeSantis said (Schlegel, Houston Chronicle, 10/10).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.