Janssen International NV drug EDURANT approved in Europe

Janssen International NV, a subsidiary of Johnson & Johnson,  announced yesterday that  the European Commission approved the drug EDURANT® as a combination treatment for HIV-1 infected patients. The approval of the drug was based on the two clinical trials (ECHO and THRIVE) that demonstrated the efficacy, tolerability, and safety of the EDURANT®.  Using EDURANT®, 90.2 percent of patients reached a viral load that was undetectable at week 48 of the study when compared with the 83.6 percent treated with the standard care drug efavirenz. Though the percentages are close, the advantage EDURANT® has over efavirenz is the ease with which it is tolerated; there was more than a 50 percent reduction in rashes, dizziness, dream/nightmare abnormalities, and lipid abnormalities. With it’s daily dose of 25mg, EDURANT® is the smallest antiretroviral agent available.


SOURCE: Johnson & Johnson Press Release