Pfizer HIV Drug Seems Safe for New Use -- FDA Staff

On Tuesday, the Food and Drug Administration said Pfizer's HIV drug Selzentry appears to be "well tolerated" in patients with a certain variation of HIV-1 who have not yet begun taking medications. Selzentry, also known by its generic name maraviroc, is already approved for use in combination with other drugs by treatment-experienced HIV patients. Pfizer is seeking approval for Selzentry to be taken with other antiretroviral drugs by previously untreated patients.

Pfizer said its trial of Selzentry found the drug is safe and effective. As many HIV drugs as possible are needed on the US market, it noted. "Although there are other good treatment options available for patients, more are needed to meet the needs of a heterogeneous patient population," the company said on Tuesday.

In a staff document, FDA said a review of its database found no new reported safety concerns in HIV patients already taking Selzentry. The agency said its analysis backed Pfizer's findings that the drug reduced HIV in patients compared with those taking efavirenz, which is marketed as Sustiva by Bristol-Myers Squibb.

FDA released its document ahead of a public meeting on Thursday when the agency will ask an outside expert panel for a recommendation on whether to approve wider use of Selzentry. FDA typically follows its advisers' advice.

If approved for use by treatment-naïve patients, Selzentry would only be indicated for adults with chemokine (c-c motif) receptor 5, or CCR5, tropic HIV-1, FDA said.

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