European agency rejects Serostim

By Advocate.com Editors

Originally published on Advocate.com April 30 2003 11:00 PM ET

The European Medicines Evaluations Agency on Monday announced that its scientific committee has rejected an application by Serono to market its anti-wasting drug Serostim to AIDS patients in Europe. The drug is approved for the treatment of AIDS-related wasting in the United States. In a statement, the agency said there was concern about the long-term safety of the medication and that long-term efficacy data also was lacking. Serostim is a recombinant human growth hormone that has been shown to increase muscle mass in those taking the medication.