TMC 114 recommended for conditional approval in Europe
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