Posted by Michael Wonder on 20 May 2017
Merck receives CHMP positive opinion recommending approval of Isentress (raltegravir) 600 mg in the European Union
19 May 2017 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of Isentress (raltegravir) 600 mg film coated tablets, in combination with other anti-retroviral medicinal products, for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 40 kg.
In adults and paediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of Isentress 400 mg twice daily. The recommendation will now be reviewed by the European Commission for marketing authorisation in the European Union.
A decision on approval is expected in the second half of 2017.
