Sep 24 2007
Drug giant Pfizer has been given approval for it's new HIV drug Celsentri to go on sale in Europe.
The European Commission has passed Celsentri (maraviroc) for sale in the European Union following it's approval by the Food and Drug Administration (FDA) in the U.S. last month.
Pfizer Inc. is the world's largest drug company and Celsentri is expected to be a big money earner for the company which has been affected by losing it's patent protection for the cholesterol busting drug Lipitor.
Celsentri is to be used in patients for whom other medicines have failed and whose HIV strain is linked to the CCR5 receptor.
Celsentri works by blocking the CCR5 co-receptor that acts as the main entry for the HIV virus into healthy immune cells.
It is the first CCR5 antagonist and belongs to a new class of drugs that prevent oral entry; HIV drugs currently used target the virus itself.
The EU approval for Celsentri comes after ongoing clinical trials which have indicated that patients who received both maraviroc and optimized background therapy (OBT) had an undetectable viral load at 48 weeks when compared to patients who were given OBT only.
In the trials, called 'MOTIVATE', patients were either given OBT or Maraviroc plus OBT.
The Maraviroc plus OBT group were also found to have greater viral load reduction.
The most common side effects for both groups included diarrhoea, nausea and headache.
The drug is sold as Selzentry in the United States.