HIV Treatment Bulletin - Vol. 7, No. 11/12, November/December 2006

On 14 December the European Medicines Agency (EMEA) recommended granting of a conditional marketing authorisation for the protease jnhibitor darunavir (brand name Prezista, formerly TMC-114).

This means that darunavir may be fully approved within 90 days and be available in the 25 countries of the EU.

Conditional marketing authorisations are granted for medicines that are likely to have a significant benefit for patients, before all of the formal studies into its efficacy and safety have been completed.

Darunavir needs to be used with a boosting dose of 100mg ritonavir and was approved in the U.S. in June.

The most common reported adverse reactions included diarrhoea, headache, fatigue, vomiting and hypertriglyceridaemia. A pharmacovigilance plan for darunavir, as for all medicinal products, will be implemented as part of the marketing authorisation.

Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC) which will be published in the European Public Assessment Report (EPAR) and will be available in all official European Union languages after the conditional marketing authorisation has been granted by the European Commission.

Source: EMEA report, 15 December 2006

2006-11-10
IB060711-16

©2006. I-BASE HIV Treatment Bulletin. Permission to reproduce courtesy of HIV i-Base, Third Floor East, Thrale House, 44-46 Southwark Street, London SE1 1UN - T: +44 (0) 20 7407 8488 F: +44 (0) 20 7407 8489

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2006. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2006. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.