US FDA Fast Tracks Drug for Treatment of Cytomegalovirus Infection

A developmental drug for the treatment of Cytomegalovirus (HCMV) infection has been granted Fast Track status by the [US] Food and Drug Administration (FDA).

Fast Track is an FDA designation reserved for innovative products intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for those conditions. Fast Track designation generally facilitates development and expedites the review and approval process.

The anti-HCMV drug Letermovir was developed by AiCuris GmbH & Co KG (Wuppertal, Germany), a privately held company devoted to research, and clinical development of innovative and resistance-breaking drugs for the treatment of viruses and nosocomial bacterial infections.

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 of the drug’s treatment efficacy from this trial are expected by the end of 2011.

“Having obtained Orphan Drug status in the European Union, receipt of Fast Track designation for Letermovir in the United States is another significant milestone for AiCuris,” said Dr. 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.”

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AiCuris GmbH & Co KG