European drug approvals: amprenavir, ddI EC, Trizivr and Kaletra


Glaxo Wellcome has received European Union approval of its HIV drug amprenavir (AgeneraseTM), the company’s first protease inhibitor (PI). Amprenavir, which would be used with other antivirals to treat HIV in adults and children, is already approved and marketed in the United States.

Enteric coated didanosine (ddI)

The European Union (EU) has approved Bristol-Myers Squibb’s capsules of enteric coated ddI for once-daily administration. The capsules, are a new formulation of ddI which is resistant to gastric acid and therefore does not require the co-administered buffer agent. The buffering agent was thought to be responsible for much of the gastrointestinal intolerance associated with the previously approved version of the drug. The buffered ddI was originally approved in the EU in 1991.

Abacavir/zidovudine/lamivudine co-formulation (Trizivirâ„¢)

The European Union has awarded approval to Glaxo Wellcome for its co-formulated combination anti-HIV therapy TrizivirTM. This is a combination of abacavir, zidovudine and lamivudine in one pill.

ABT-378/r (lopinavir/ritonavir)

Abbott Laboratories said on Wednesday that it has submitted an application to European regulators seeking approval for AIDS and HIV treatment ABT-378/r. The Abbott Park, Illinois-based company said that 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 (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 2 phase II trials in PI-naive and PI-experienced patients and a phase III study in naive patients. A phase I/phase II paediatric trial in 100 children was also included in the submission, Abbott said.

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