Fuzeon (enfuvirtide) which has been developed by Roche and Trimeris has received a positive opinion from the European Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the EMEA (European Agency for the Evaluation of Medicinal Products), recommending the granting of a marketing authorization.
The proposed indication for Fuzeon is for “use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens. In deciding on a new regimen for patient who has failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.” The CPMP's positive opinion will now be proposed for approval by the European Commission.
This announcement follows approval of Fuzeon last week by the US Food and Drug Administration (FDA) in the United States. Submissions for marketing authorisations have also been made in Australia, Canada and Switzerland.
Fuzeon's unique mode of action is not comparable to conventional anti-HIV drugs, as it blocks the virus before entering the human immune cell.
“This is excellent news for European HIV patients who are becoming resistant to currently available treatments” commented William M. Burns, Head of Roche Pharmaceuticals. "Fuzeon is yet another example of Roche's long-standing commitment to advancing the treatment of HIV and represents a major advance in the fight against HIV."
Fuzeon was studied in two large, international phase III studies – TORO 1 (T-20 vs. Optimised Regimen Only) and TORO 2. These studies confirmed the activity of Fuzeon at 24 weeks of therapy against drug resistant forms of the virus. Treatment-experienced patients receiving Fuzeon plus an individualised regimen of standard anti-HIV drugs were twice as likely to achieve undetectable levels of HIV in the blood (less than 400 copies/mL; 32.7%; 216/661 patients) than patients who received an individualised drug regimen without Fuzeon (15.0%; 50/334 patients). These 24 week data, as well as the preliminary 48 week data, showed that in treatment experienced patients with few remaining options, the addition of Fuzeon to an individualised combination of anti-HIV medicines reduced the amount of virus in the blood and increased the number of CD4 cells more than the use of an individualised combination of anti-HIV medicines alone.
Fuzeon is administered as a twice-daily subcutaneous injection. Local injection site reactions were the most frequent adverse events associated with the use of Fuzeon. In the TORO studies, 98 percent of patients had at least one local injection site reaction. In this treatment-experienced patient population, three percent of patients discontinued treatment with Fuzeon as a result of injection site reactions.
The addition of Fuzeon to background antiretroviral therapy generally did not increase the frequency or the severity of the majority of adverse reactions. The majority of adverse reactions were of mild or moderate intensity. Hypersensitivity reactions have occasionally been associated with Fuzeon therapy and in rare cases have recurred on re-challenge. A preliminary analysis of longer term safety data has identified an increased rate of some bacterial infections, primarily pneumonia, in patients treated with Fuzeon.
There is a significant and growing need for new antiretrovirals that are active against strains of HIV that are resistant to the currently available medications. As Fuzeon represents the first new class of HIV therapy to be introduced since 1996, there is likely to be a considerable demand for the drug which may exceed initial supplies. In view of the potential for demand to exceed supply, Roche and Trimeris will carefully manage available drug to ensure that people who initiate therapy have uninterrupted supply.
Currently in Europe there are patients receiving Fuzeon through Early Access Programmes and clinical studies. Roche and Trimeris are committed to ensuring that all these patients as well as those who start therapy following approval have a guaranteed supply of Fuzeon. Increased access to Fuzeon will be in step with increased supply output.