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AiCuris’ Letermovir receives Fast Track designation

Monday, August 29, 2011 12:58 PM

AiCuris announced today that the FDA has granted Fast Track designation for one of its lead drugs, AIC246, an inhibitor of the human cytomegalovirus (HCMV).

“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 Helga Rübsamen-Schaeff, CEO of AiCuris. “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. This data will demonstrate that Letermovir has no clinically significant drug-drug interactions when co-administered with immunosuppressive drugs.

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