AiCuris’ HCMV Drug Letermovir (AIC246) Receives Fast Track from FDA
Product News Aug 29, 2011
AiCuris has announced that the Food and Drug Administration (FDA) of the United States has granted Fast Track designation for one of the company’s lead drugs, AIC246, an inhibitor of the human cytomegalovirus (HCMV).
Fast Track designation is an FDA status reserved for products that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for those conditions.
Fast Track designation can also potentially facilitate development and expedite the review and approval process.
“Having obtained Orphan Drug status in the EU, receipt of Fast Track designation for Letermovir in the U.S. is another significant milestone for AiCuris" said Prof. Helga Rübsamen-Schaeff, CEO of AiCuris.
Prof. Rübsamen-Schaeff continued, “It will hopefully facilitate the regulatory process for this drug and supports our view that Letermovir has the potential to become the treatment of choice for patients at risk to develop severe and life-threatening HCMV disease, such as transplant recipients, newborns, patients in intensive care, certain cancer patients and HIV patients. These patients currently have only limited treatment options, due to the adverse side-effect profiles of existing drugs.”
Letermovir is currently being evaluated in an international Phase IIb trial, which - based on the evaluation of an independent safety monitoring committee - has confirmed a positive safety profile. Results on efficacy from this trial are expected by the end of 2011.
Dr. Holger Zimmermann, CSO of AiCuris, will present new data on Letermovir during the upcoming 51st ICAAC in Chicago.
This data will demonstrate that Letermovir has no clinically significant drug-drug interactions when co-administered with immunosuppressive drugs (Session 005 on 17th September 2011 at 11:30 Uhr, Presentation A2-045b).