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.
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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.
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Following this positive opinion, the European Commission will now review the recommendation for marketing authorisation in the European Union.
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By GlobalDataThe 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.
