Raltegravir takes key step towards European approval

Raltegravir (Isentress) has moved a key step closer to formal approval in Europe. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) recommended that the drug receive conditional marketing approval for use with other antiretroviral drugs by patients whose anti-HIV therapy is unable to control viral load.

The drug belongs to a novel class of antiretrovirals called integrase inhibitors. It works against HIV’s integrase protein, inhibiting the virus’s integration into human cells . It has no known cross-resistance with any other currently available antiretroviral making it an attractive option for heavily treatment-experienced individuals.

Raltegravir’s approval is based upon the results from the BENCHMARK I and II studies. Data presented to a major conference in September showed that the drug had a durable anti-HIV effect in patients with limited treatment options.

Formal approval is required from the European Commission before the drug can be marketed in Europe, but the CHMP recommendation is an important step in this process.

In October, raltegravir received accelerated approval from US drug regulatory authorities.

The approved dose of raltergravir is 400mg twice daily. Side-effects include diarrhoea, nausea, and headache.

Although raltegravir will initially be used as a therapy for treatment-experienced patients, encouraging data regarding its safety and efficacy in treatment-naïve patients were presented to this year’s International AIDS Society Conference in Sydney.