FDA Approves New Drug Tivicay
BY Trudy Ring
August 15 2013 3:51 PM ET
The U.S. Food and Drug Administration this week approved Tivicay, a new drug to be used in combination with other medications to treat HIV.
Tivicay (generic name dolutegravir) is an integrase inhibitor, meaning it interferes with integrase, one of the enzymes HIV needs to reproduce. The FDA approved it Monday for use in patients new to HIV treatment and those who have taken other drugs. It comes as a 50-milligram tablet to be taken once or twice daily, depending on the patient, at any time of day, with or without food. It is expected to be available in pharmacies within two weeks.
It is the first new drug developed by Viiv Healthcare, a company established by GlaxoSmithKline and Pfizer in 2009 to focus on creating new HIV treatments.
Tivicay, evaluated against other medications in clinical trials, expands the options for treating HIV, FDA and drug company officials said. “HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”
Viiv Healthcare chief medical officer John Pottage noted, “Tivicay provides a new opportunity for health care professionals to choose the right regimen for their patients, providing a focal point around which to individualize therapy. HIV treatment should not be a ‘one size fits all’ paradigm. … As HIV has become a chronic disease, and people now are living for a long time with the disease, we know that new medicines will always be needed.”
See more about the drug in the video below.