Merck , known as MSD outside the United States and Canada announced that the U.S. FDA has approved ISENTRESS® (raltegravir), the company’s integrase inhibitor, for use in combination with other antiretroviral agents, for the treatment of HIV-1 in neonates – newborn patients from birth to four weeks of age – weighing at least 2 kg. The FDA approval for the use of ISENTRESS in the treatment of HIV-1 in neonates is supported by results from an open-label, multicenter clinical study, IMPAACT P1110, evaluating the safety and pharmacokinetics of ISENTRESS for oral suspension in 42 full-term HIV-1 exposed newborns at high risk for acquiring HIV-1 infection from their mothers.
“Because clinical research on the use of antiretroviral drugs to treat newborns with HIV-1 infection has been limited, few antiretroviral agents are approved for this population,” said Dr. Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories. “With this FDA approval, ISENTRESS becomes the only integrase inhibitor approved in the U.S. for the treatment of HIV-1, in combination with other antiretroviral agents, for neonates weighing at least 2 kg. This achievement underscores Merck’s unwavering commitment to the development of treatment options for HIV-1.”
ISENTRESS does not cure HIV-1 infection or AIDS. Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis. Immediately discontinue treatment with ISENTRESS and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develops and monitor clinical status, including liver aminotransferases closely. For more information, see “Selected Safety Information” below.
The use of ISENTRESS is not recommended in pre-term newborns or infants weighing less than 2 kg, as no data are available in these populations. If the mother has taken ISENTRESS or ISENTRESS HD within two to 24 hours before delivery, the newborn’s first dose should be given between 24 to 48 hours after birth.
About IMPAACT P1110
The IMPAACT P1110 study used a two-cohort design. Cohort 1 newborns received two single doses of ISENTRESS for oral suspension: the first within 48 hours of birth and the second at seven to ten days of age. Cohort 2 newborns received daily dosing of ISENTRESS for oral suspension for six weeks at different weight-based doses. Sixteen newborns were enrolled in Cohort 1 (10 were exposed to ISENTRESS in utero and 6 were not) and 26 in Cohort 2 (all unexposed to ISENTRESS in utero); all infants received a standard of care antiretroviral drug regimen for prevention of mother to child transmission. All enrolled infants were followed for safety for 24 weeks. At the completion of the study, all patients were HIV-1 negative. The safety profile of ISENTRESS in this study was comparable to that observed in adults.
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola.
For more information, visit www.merck.com