Abbott seeks European approval of AIDS/HIV drug
ABBOTT PARK, Ill., July 5 (Reuters) - Drug maker Abbott Laboratories Inc. (NYSE:ABT - news) said Wednesday it submitted an application to European regulators seeking approval for AIDS and HIV treatment ABT-378/r.
The Abbott Park, Illinois-based company said the application was submitted to the European Agency for the Evaluation of Medical Products for review based on clinical data from studies conducted around the world.
ABT-378/r, whose chemical name is lopinavir/ritonavir, is a protease inhibitor (PI) and was filed under the trade name Kaletra.
The European regulatory submission of ABT-378/r is based on Phase II and Phase III trials in more than 700 patients from a broad range of treatment groups including those new to antiretroviral therapy as well as those who have failed other drug regimens.
The primary studies include two Phase II trails in PI-naive and PI-experienced patients, and a Phase III study in naive patients. A Phase I and Phase II pediatric trial in 100 children was included in the submission, Abbott said.
``Many physicians reserve the most potent drugs for use in patients who have failed other drugs,'' Dr. Eugene Sun, head of Abbott's antiviral drug development, said in a statement. ``Clinical trials were designed to demonstrate that ABT-378/r is useful in a broad range of patients, reflecting its potency and tolerability in the patients studied.''
Lopinavir is co-formulated with a small amount of ritonavir. The small dose of ritonavir serves to boost levels of lopinavir to create high and sustained blood levels of lopinavir, Abbott said.
In vitro studies suggest that these drug levels provide much greater anti-viral effect than any other protease inhibitor, the company said. High drug levels in the blood ensure sustained viral suppression, thus guarding against the emergence of resistant virus.
The emergence of new mutations of the HIV virus has made the development of new treatments more important, Abbott said.
Based on the need for new treatment options, the company initiated its early access programme prior to regulatory submission and market authorisation to provide ABT-378/r to HIV-positive patients for whom the drug is necessary to construct a viable treatment regimen. The programme was designed by working closely with key regulatory agencies and representatives of several HIV treatment organisations and currently is available to 5,200 patients in 17 countries.
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