In a needed bit of good news, the drugmaker says the FDA granted accelerated approval for Selzentry, which until now known as maraviroc. The HIV med, which is expected to become available next month, will compete with a similar Merck drug that is widely expected to receive regulatory approval this fall.

The FDA action comes just a few weeks after the Selzentry approval was inexplicably delayed. At the time, Pfizer would only say the hold-up was due to discussions over product labeling and that further clinical studies weren’t required. However, the drugmaker noted the accelerated approval is based on 24-week data, and longer-term data will be required before traditional approval is considered.

Selzentry is the first in a new class of oral AIDS drugs known as CCR5 antagonists, which block a receptor that is a key entry route for T-cells. The med is supposed to block viral entry into white blood cells, and reduce viral loads while increasing T-cell counts in patients who have already been undergoing HIV treatment and are infected with a specific type of HIV. The drug works by stopping the R5 virus on the outside surface of cells before it enters, rather than fighting the virus inside as do oral HIV meds.

The product label includes a boxed warning about liver toxicity (hepatoxicity) and a statement in the Warnings/Precautions section about the possibility of heart attacks, according to an FDA statement. And its safety and effectiveness of maraviroc have not been established in adult and pediatric patients who have never been treated with any other HIV drug.

Coincidentally, the approval comes just a few days after three senior HIV marketing managers left the drugmaker, which has been conducting an internal investigation into allegations that maraviroc was improperly promoted to doctors before FDA approval, as well charges that unapproved materials and CME funds were used to promote the older Viracept AIDS drug.