Raltegravir approved in Europe for treatment-naive patients
On 15th September 2009, raltegravir (Isentress) was been granted an expanded licence from the European Union Commission for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients, including adult patients starting HIV-1 therapy for the first time (treatment-naive), as well as treatment-experienced adult patients.
The safety and efficacy of the drug has not been established in patients below 16 years of age.
The EU Commissions decision is applicable to the 27 Member States of the European Union (EU), including France, Germany, Italy, Spain and the United Kingdom as well as to Iceland and Norway.
Source: Merck press release