Merck’s Isentress receives CHMP positive opinion to treat HIV-1 infection
Merck’s Isentress (raltegravir) 600mg film-coated tablets have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), for the treatment of HIV-1 infection in adults and paediatric patients.
CHMP adopted this positive opinion for Isentress when administered in combination with other anti-retroviral medicinal products.
Isentress is Merck's integrase inhibitor for HIV-1 infection treatment in adult and paediatric patients aged four weeks and older and weighing at least 3kg as part of combination HIV therapy.
It inhibits the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity.
Isentress has already received approval as a part of a combination therapy in 112 countries to treat HIV-1 infection in adults.
Following this positive opinion, the European Commission will now review the recommendation for marketing authorisation in the European Union.
The decision is expected in the second half of this year.
Merck Research Laboratories global clinical development, infectious diseases and vaccines senior vice president Dr Eliav Barr said: “The CHMP’s positive opinion recommending the approval of Isentress 600mg film-coated tablets is an important step toward a new option for people living with HIV who are looking for once-daily dosing, as part of an HIV treatment regimen, with proven efficacy and safety.”
The opinion was based on findings from the ONCEMRK trial, an ongoing Phase III multicentre, double-blind, randomised, active comparator-controlled clinical trial designed to evaluate the efficacy and safety of Isentress at 1,200mg.
The drug was assessed in combination with emtricitabine + tenofovirdisoproxil fumarate in previously untreated HIV-1 infected adults.
A once-daily dose of Isentress at 600mg (1,200mg total), when administered used as part of an HIV-1 treatment regimen, demonstrated comparable efficacy and safety compared to Isentress at 400mg after 48 weeks of treatment in different patient populations.
The once-daily formulation of Isentress is currently under review by the US Food and Drug Administration.