Pfizer’s Celsentri approved in Europe
pharmafile | September 25, 2007 | News story | Research and Development, Sales and Marketing | HIV
Pfizer's Celsentri has been approved in Europe, making it the first in a new, oral class of HIV drugs in 10 years.
Celsentri (maraviroc) is licensed for treatment-experienced adult patients with a strain of HIV linked to the CCR5 receptor.
Filippo von Schloesser, president of Italian HIV patient organisation Fondazione Nadir Onlus, said: "HIV is a significant health concern in Europe and infection rates are still increasing. Without new medicines, resistance to current treatments is one of the biggest challenges facing HIV care today.
"The approval of maraviroc will offer a new option to many people living with HIV in Europe."
European approval of Celsentri was based on 48-week data from the two ongoing double blind, placebo-controlled MOTIVATE clinical trials.
These showed that more than twice as many patients receiving Celsentri plus optimised background therapy (OBT) achieved undetectable viral load at 48 weeks compared with those receiving OBT alone.
The discovery of Celsentri goes back 10 years, when Pfizer research scientists at the company's R&D headquarters in Sandwich, Kent, designed the molecule. They found that around 1% of Europeans who lacked the genes for CCR5 receptors were the very ones resistant to acquiring HIV infection.
The drug works by preventing the virus produced by infected cells from entering uninfected cells rather than fighting HIV inside white blood cells.
Celsentri had been granted accelerated review in Europe and the US, where it was approved in August under the brand name Selzentry.
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