09-01-2012: AiCuris announced that AIC246 (Letermovir), the Company’s inhibitor against the human cytomegalovirus HCMV, has been granted Orphan Drug Designation in the US for the prevention of HCMV viremia and disease in at risk populations. This decision was made on 12 December 2011 by the FDA Office of Orphan Products Development.
Letermovir has recently successfully completed a phase IIb trial for the prophylaxis of HCMV infection and disease in bone marrow transplanted patients. Results will be announced shortly.
“After orphan drug designation was granted earlier last year in Europe, we are very pleased to have now also received this designation in the USA. For the further development of this innovative drug, the Orphan Drug Designation will provide easier access to scientific support by the agencies, which will help to develop new treatment paradigms against this dangerous virus” commented AiCuris CEO, Prof. Rübsamen-Schaeff.