Merck Sharp and Dohme receives CHMP backing for new Isentress dose

Merck Sharp and Dohme has announced that its new dosing option for the HIV therapy Isentress has been recommended for approval by the European Commission.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of Isentress in 600 mg film-coated tablets, used in combination with other antiretroviral medicinal products, for the treatment of HIV-1 infections in adults and paediatric patients.

The recommended dosage is 1,200 mg – or two 600 mg tablets – taken once daily for treatment-naive patients, or patients who are virologically suppressed on an initial regimen of twice-daily Isentress at 400 mg.

This positive opinion was based on findings from the ONCEMRK trial, an ongoing phase III trial, which showed that the new dosing regimen demonstrated comparable efficacy and safety to the 400 mg twice-daily option after 48 weeks of treatment across a variety of patient populations.

Dr Eliav Barr, senior vice-president for global clinical development, infectious diseases and vaccines at Merck Research Laboratories, said: "The CHMP's positive opinion recommending the approval of Isentress 600 mg film-coated tablets is an important step toward a new option for people living with HIV."

The recommendation will now be reviewed by the European Commission, with a decision expected in the second half of 2017.

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