FDA Approves Dolutegravir for Smaller Children with HIV

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The U.S. Food and Drug Administration this week approved a supplemental indication for the HIV integrase inhibitor dolutegravir (Tivicay), allowing its use for children age 6 years and older who weigh as little as 30 kg. The drug is currently being evaluated in younger and smaller children.

Below is an edited excerpt from a ViiV Healthcare press release describing the expanded indication.

ViiV Healthcare Announces FDA Approval to Lower the Weight Limit for Dolutegravir in Children and Adolescents Living with HIV

Reduction of weight limit to at least 30 kg means more children and adolescents will be eligible for dolutegravir

London, U.K. -- June 2016-- ViiV Healthcare today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for dolutegravir 10 mg and 25 mg oral tablets, reducing the weight limit from at least 40 kg to at least 30 kg, in ages 6 to less than 12 years old, for the treatment of HIV-1 in children and adolescents. Dolutegravir, in line with the current label, will be available for use in two pediatric populations: pediatric patients weighing at least 30 kg living with HIV-1 who are treatment naive (not previously treated) and who are treatment experienced (previously treated), as long as they have not taken an integrase inhibitor.

This approval is based on 24-week data from the Phase I/II multi-center, open-label P1093 study conducted in collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network. IMPAACT P1093 is an ongoing pharmacokinetic (PK), safety and efficacy study of dolutegravir plus optimized background regimen (OBR) in children and adolescents infected with HIV-1 in age-defined cohorts.

Results from the study show that treatment with dolutegravir plus OBR was generally well tolerated and provided efficacy through to week 24 in HIV-1 infected children and adolescents from 6 to 12 years of age weighing at least 30 kg. The adverse event (AE) profile in the study was similar to that for adults.Grade 2 AEs reported by more than one patient were decreased neutrophil count (n = 3) and diarrhoea (n = 2). There were no Grade 3 or 4 drug-related AEs reported, and no AEs led to discontinuation.

"From day one children and adolescents have been, and remain, a key focus in our drive to improve outcomes for people living with HIV," said John C. Pottage, Jr., MD, Chief Scientific and Medical Officer, ViiV Healthcare. "Through our research and development efforts, corporate social responsibility programs, partnerships and access initiatives, we have made a difference for younger populations. This approval by the FDA provides more children and adolescents the option to be treated with dolutegravir in the U.S., and supports the global UNAIDS pediatric treatment target."

According to UNAIDS, there were 3.2 million children living with HIV in 2013, and 2.1 million adolescents living with HIV in 2012, most of whom live in sub-Saharan Africa. Children and younger adolescents have a limited number of treatment options available to meet their particular needs, with many antiretroviral therapies not approved for use in these populations.

In 2014, ViiV Healthcare granted a voluntary license to the Medicines Patent Pool (MPP) and Aurobindo Pharma to allow the generic manufacture of pediatric formulations of dolutegravir without paying a royalty in 121 countries where most (99%) children with HIV live. Under the terms of these agreements, Aurobindo Pharma and generics companies sub-licensed by the MPP are permitted to manufacture the new 10 mg and 25 mg formulations of dolutegravir, subject to local regulatory approvals. This means that dolutegravir may be made available to children and adolescents weighing at least 30 kg in low-income, least developed, sub-Saharan African and middle-income countries in the future, subject to local regulatory approvals.

ViiV Healthcare is committed to further investigating the potential of dolutegravir in younger age-groups. The ongoing P1093 study is continuing the evaluation of dolutegravir in pediatric populations down to four weeks of age, weighing at least 3 kg.

About the P1093 IMPAACT study

P1093 is a Phase I/II, multi-center, open-label, non-comparative intensive pharmacokinetic and safety study of dolutegravir in combination regimens in HIV-1 infected infants, children and adolescents. The primary objectives of the study are to select a dolutegravir dose for chronic dosing; to determine the safety and tolerability of the dose, to evaluate the steady-state pharmacokinetics of dolutegravir in combination with other antiretrovirals and to determine the dose of dolutegravir that achieves a targeted AUC24 (primary PK endpoint) and C24h (secondary PK endpoint) in children and adolescents.

 About Tivicay (dolutegravir)

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block 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. Tivicay is approved in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.

See full press release forImportant Information about Tivicay (dolutegravir)

Full US Prescribing Information for Tivicay is available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organization working to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organizations, patient groups and other stakeholders to prioritize, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with six patent holders for twelve HIV antiretrovirals and for one hepatitis C direct-acting antiviral. Its generic partners have distributed more than three billion doses of low-cost medicines to 117 countries. The MPP was founded and remains fully funded by UNITAID.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi (TYO: 4507) joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

6/16/16

Source

ViiV Healthcare. ViiV Healthcare Announces FDA Approval to Lower the Weight Limit for Dolutegravir in Children and Adolescents Living with HIV. Press release. June 10, 2016.