FDA News
August 13, 2013
The FDA on Monday approved ViiV Healthcare’s HIV drug dolutegravir under the brand name Tivicay.
The drug was approved for adults with HIV but is limited to certain children 12 years and older with HIV. Tivicay was granted priority review status earlier this year.
The company — a collaboration between GlaxoSmithKline, Pfizer and Shionogi — has also filed for approval in Canada and the EU.
Approval of the drug for adults was based on four clinical trials involving more than 2,500 patients. In some trials, patients were treated with the drug versus other integrase inhibitors such as Merck’s Isentress (raltegravir) and Gilead’s elvitegravir. In one of the trials, Tivicay outshone Gilead’s Atrilpa, a fixed-dose combination of efavirenz, emtricitabine and tenofovir.
The CDC notes about 50,000 Americans are infected with HIV annually and approximately 15,500 died from the disease in 2010 alone. "HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," said Edward Cox, a director at CDER, upon approval of Tivicay. He added the drug is an addition to the arsenal of HIV drugs now available to physicians and patients.
The FDA said a fifth trial was able to prove the pharmacokinetic effects of the drug on children, and established a reasonable safety and efficacy profile of the drug in that cohort.
The most common side effects of Tivicay are insomnia and headaches. Serious side effects include hypersensitivity and abnormal liver function in patients also infected with hepatitis B and/or C.
The FDA on Monday approved ViiV Healthcare’s HIV drug dolutegravir under the brand name Tivicay.
The drug was approved for adults with HIV but is limited to certain children 12 years and older with HIV. Tivicay was granted priority review status earlier this year.
The company — a collaboration between GlaxoSmithKline, Pfizer and Shionogi — has also filed for approval in Canada and the EU.
Approval of the drug for adults was based on four clinical trials involving more than 2,500 patients. In some trials, patients were treated with the drug versus other integrase inhibitors such as Merck’s Isentress (raltegravir) and Gilead’s elvitegravir. In one of the trials, Tivicay outshone Gilead’s Atrilpa, a fixed-dose combination of efavirenz, emtricitabine and tenofovir.
The CDC notes about 50,000 Americans are infected with HIV annually and approximately 15,500 died from the disease in 2010 alone. "HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," said Edward Cox, a director at CDER, upon approval of Tivicay. He added the drug is an addition to the arsenal of HIV drugs now available to physicians and patients.
The FDA said a fifth trial was able to prove the pharmacokinetic effects of the drug on children, and established a reasonable safety and efficacy profile of the drug in that cohort.
The most common side effects of Tivicay are insomnia and headaches. Serious side effects include hypersensitivity and abnormal liver function in patients also infected with hepatitis B and/or C.