Celesentri, known as Maraviroc in the U.S., will pass on to the European Commission for final approval.
Pfizer has received a positive opinion from the EMEAs advisory committee on its HIV drug. Maraviroc, a CCR5 antagonist that will be marketed in Europe as Celsentri, could mark the first new type of medication for this disease in more than a decade, according to Pfizer.
Maraviroc’s approval in the U.S. was unexpectedly stalled last month. In spite of an FDA panel unanimously voting in favor of the drug, the agency did not give it the green light, instead it issued an approvable letter. Pfizer did not disclose exactly what additional information was needed or if another clinical trial was expected.
The Committee for Medicinal Products for Human Use (CHMP), like the FDA’s Antiviral Drugs Advisory Committee, voted to recommend marketing authorization of Celsentri to be used in combination with other antiretroviral agents for treatment-experienced adult patients where only CCR5-tropic virus is detectable. Pfizer anticipates a final decision from the European Commission in the coming months.
Maraviroc works extracellularly, preventing the virus from invading human cells. Rather than fighting HIV inside white blood cells, the drug stops viral entry by blocking its predominant access route, the CCR5 co-receptor.
