FDA grants fast track status to AiCuris Letermovir

Recently, the company has confirmed positive results from a Phase IIb trial evaluating Letermovir, an inhibitor of the human cytomegalovirus (HCMV).

AiCuris CEO Helga Rubsamen-Schaeff said having obtained orphan drug status in the EU, receipt of fast track designation for Letermovir in the US is another significant milestone for the company.

"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," Rubsamen-Schaeff said.