Date: 2013-08-16
Type of information: Granting of a Market Authorisation in the EU
Product name: Tivicay®
Compound: dolutegravir
Therapeutic area: Infectious diseases
Action mechanism: Dolutegravir is an investigational integrase inhibitor (INI). INI blocks HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Company: ViiV Healthcare (UK-USA)
Disease: HIV-1 infection
Latest news: * On November 22, 2013, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Tivicay® in combination with other antiretroviral medicines for the treatment of adults and adolescents over 12 years of age infected with HIV-1.Tivicay® can be used in adult patients with and without resistance to the integrase class and in adolescents infected with HIV-1 without resistance to the integrase class.Tivicay® has demonstrated its efficacy in large scale studies covering previously untreated patients as well as patients with advanced treatment histories and resistant to multiple classes of HIV medicines. Tivicay® also demonstrated a high barrier to resistance meaning that it is less prone to resistance development. In the absence of integrase class resistance, the dosing regimen is one tablet a day. In the presence of such resistance, Tivicay® should be administered twice a day with food.* On August 12, 2013, the FDA has approved Tivicay® (dolutegravir), a new drug to treat HIV-1 infection.Tivicay® is a pill taken daily in combination with other antiretroviral drugs. It is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay® is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.Tivicay®’s safety and efficacy in adults was evaluated in 2,539 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Tivicay® or Isentress (raltegravir), each in combination with other antiretroviral drugs, or Atripla®, a fixed-dose combination of efavirenz, emtricitabine and tenofovir. Results showed Tivicay®-containing regimens were effective in reducing viral loads.A fifth trial established the pharmacokinetics, safety and activity of Tivicay® as part of treatment regimens for HIV-infected children ages 12 years and older weighing at least 40 kg who have not previously taken integrase strand transfer inhibitors.Common side effects observed during clinical studies include difficulty sleeping (insomnia) and headache. Serious side effects include hypersensitivity reactions and abnormal liver function in participants co-infected with hepatitis B and/or C. The Tivicay® label gives advice on how to monitor patients for the serious side effects.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2013-08-12
UE authorization: 2014-01-16
Favourable opinion UE: 2013-11-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
