Pfizer’s anti-HIV drug Selzentry (maraviroc) has been granted full (traditional) approval for adults with CCR5-tropic HIV-1 by the US Food and Drug Administration (FDA).
The treatment is part of a new class of drugs styled CCR5 antagonists, which are intended for use after a patient is diagnosed with the disease, also known as “R5 virus”.
Selzentry stops the virus getting into CD4 T-cells that express the CCR5 co-receptor rather than fighting it inside the cell, as do all other classes of oral HIV medicines.
W David Hardy, from Cedars-Sinai Medical Centre, said: “New, effective and well-tolerated treatment options are critical for treatment-experienced persons living with HIV infection.
“Selzentry, the first oral entry inhibitor, has proven to be an effective and well-tolerated treatment option for treatment-experienced patients whose HIV has become resistant to other treatments, but remains susceptible to this new class of medications.”
Accelerated conditional approval is granted to medicines that provide a meaningful therapeutic advantage for serious or life-threatening diseases.
Said Dr Howard Mayer, Pfizer’s executive director and development team leader for HIV/AIDS: “Selzentry has been on a long journey, from its initial discovery by Pfizer scientists in 2000 to this full FDA approval.”
Copyright Press Association 2008