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Abbott Laboratories Submits Application to European Regulatory Authorities
Seeking Approval for ABT-378/r for the Treatment of HIV
Abbott Park, Ill. (ots-PRNewswire) - Abbott Laboratories (NYSE: ABT) announced today that it has submitted an application to the European Agency for the Evaluation of Medicinal Products (EMEA) seeking approval for ABT-378/r (lopinavir/ritonavir), a protease inhibitor (PI) for the treatment of HIV and AIDS. The European application was submitted for review based on clinical data from studies conducted around the world, including 27 sites throughout Europe. Abbott will continue its ongoing dialogue with the regulatory authority regarding the marketing authorization for ABT-378/r to address the urgent public health need for new medications to treat HIV/AIDS. ABT-378/r was filed under the trade name Kaletra(TM).
"The development of ABT-378/r is the result of extensive research by Abbott scientists to design a new protease inhibitor that achieves the balance of potency, tolerability and long-term durability," said William G. Dempsey, senior vice president, international operations at Abbott Laboratories. "Clinical studies of ABT-378/r have demonstrated excellent long-term efficacy and tolerability among a wide range of patients."
The EMEA 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 naive to antiretroviral therapy as well as those who have failed other drug regimens. The primary studies include two Phase II trials in PI-naive and PI-experienced patients (72 weeks), and a Phase III study in naive patients (24 weeks). In addition, a Phase I/II pediatric trial in 100 children (24 weeks) was included in the submission.
"Many physicians reserve the most potent drugs for use in patients who have failed other drugs," said Eugene Sun, M.D., head of antiviral drug development at Abbott. "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. In vitro studies suggest that these drug levels provide much greater anti-viral effect than any other PI. 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. It is critical to continue to provide effective options to help prevent and fight drug-related resistance.
Based on the urgent need for new treatment options, Abbott initiated its Early Access Program prior to regulatory submission and market authorization to provide ABT-378/r to HIV-positive patients for whom the drug is necessary to construct a viable treatment regimen. The program was designed by working closely with key regulatory agencies and representatives of several HIV treatment organizations and currently is available to 5,200 patients in 17 countries worldwide.
Abbott Laboratories has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV in the blood, and remains the leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. With ABT-378/r, Abbott has developed two protease inhibitors.
Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing f pharmaceutical, diagnostic, nutritional and hospital products. The company employs 57,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
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