Merck: FDA Has Approved Pediatric Version of HIV Therapy



Merck & Co. Inc. (NYSE:MRK) announced Wednesday that a pediatric version of the HIV therapy medication Isentress has been approved by the Food and Drug Administration. Now, Isentress can be used in combination with other antiretroviral agents to treat HIV in patients four weeks of age and older.

For a pediatric patient to take Isentress, they need to be at least four weeks old and weigh at least 3 kilograms (approximately 6.6 pounds), but less than 20 kilograms (40 pounds). When being tested, Isentress was taken through oral suspension, chewable tablets, and film-coated tablets. According to the release, the oral suspension formulation will be available to pediatric patients in the U.S. starting in the third quarter of 2014.

“We are very pleased that ISENTRESS can now be a part of a treatment regimen for HIV-1 infected infants and children as young as four weeks of age,” Hedy Teppler, executive director of clinical research at Merck Research Laboratories, said in the press release.