About Fast Track Designation
Chimerix has been granted two FDA Fast-Track Designations for CMX001: for the treatment of adenovirus disease and for the treatment of smallpox. The FDA's "Fast Track" program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and that demonstrate the potential to fill an unmet medical need. The designation typically enables a Company to submit a New Drug Application (NDA) on a "rolling" basis with ongoing FDA review during the submission process. NDAs with Fast Track designation are also usually granted Priority Review by FDA at the time of NDA submission.
Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health.
The company's lead candidate, CMX001, is being developed as a potential broad spectrum, oral antiviral product for the treatment or prevention of life-threatening double-stranded DNA (dsDNA) viral diseases. To date, more than 550 patients have been dosed with CMX001 in placebo-controlled clinical trials and open-label treatment protocols, including more than 250 individuals who have received CMX001 under Emergency Investigational New Drug Applications (EINDs)or as part of the CMX001-350 Open-Label Study to help treat life-threatening dsDNA viral diseases for which there were no other therapeutic options.
Clinical studies of CMX001 include an ongoing Phase 2 study of the prevention/control of CMV in adult hematopoietic stem cell transplant patients (CMX001-201); a Phase 2 study for the treatment of AdV infection in pediatric and adult hematopoietic stem cell transplant patients (AdV HALT Trial/CMX001-202)
|SOURCE Chimerix, Inc.|
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