DURHAM, NC –Trimeris and Roche are making the new HIV drug Fuzeon available in European countries that want to participate in so-called “special license sales” before the drug has been approved formally, the companies announced this morning.
Fuzeon could receive approval from the US Federal Drug Administration as early as March 16.
The European program is part of an early access program the companies announced late last year so that AIDS patients with limited treatment options could get quick access to Fuzeon.
Some 600 patients in the US already are receiving Fuzeon at no charge under a US early access program. The companies said the 600 would continue to receive the drug free until formal approval from the FDA is received, prices are set, and reimbursement mechanisms put in place.
European users will have to pay for the drug based on prices set in each country, the companies said.