GlaxoSmithKline (GSK) has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMEA (European Agency for the Evaluation of Medicinal Products), recommending the granting of a marketing authorization for a new HIV medication.
This medication, with the proposed trade name Kivexa in the EU, combines two antiretrovirals in one tablet dosed once a day with no food or fluid requirements. Kivexa is comprised of two widely used nucleoside reverse transcriptase inhibitors (NRTIs), Epivir (lamivudine, 3TC) and Ziagen (abacavir sulfate, ABC), for the treatment of HIV infection in adults in combination with other antiretroviral medications. The CHMP positive opinion will now be proposed for approval by the European Commission, an official statement said.
"The CHMP positive opinion is good news as Kivexa will provide clinicians and HIV-infected patients with a flexible, well-tolerated and potent combination of two NRTIs that have been widely used in antiretroviral therapy for years," commented Didier Lapierre, vice president of Infectious Diseases, GSK Europe.