Gilead's Vitekta gains European Commission approval

The European Commission has granted marketing authorization for US biotech firm Gilead Sciences’ (Nasdaq: GILD) Vitekta (elvitegravir 85mg and 150mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir.

Vitekta is indicated for use as part of HIV treatment regimens that include a ritonavir-boosted protease inhibitor. The drug interferes with HIV replication by blocking the virus from integrating into the genetic material of human cells. In clinical trials, Vitekta was effective in suppressing HIV among patients with drug-resistant strains of HIV. According to analysts polled by Bloomberg, the drug as a single agent is forecast to reach sales of $363 million at peak.

"Vitekta offers people with HIV who have failed prior therapy or who have developed drug resistance an important new treatment option," said Norbert Bischofberger, executive vice president, R&D, and chief scientific officer of Gilead Sciences, adding: "Vitekta is only the second integrase inhibitor to become available in the European Union."