FDA Grants Chimerix Fast Track Designation for CMX001 for the Prevention of Clinically Significant Cytomegalovirus Infection
Chimerix, Inc., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CMX001 for the prevention of cytomegalovirus (CMV) infection. CMX001 is the company's broad spectrum, oral nucleotide analog lipid-conjugate that blocks replication of double-stranded DNA (dsDNA) viruses.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
CMX001 has completed Phase 2 clinical development for the prevention of CMV infection in adult hematopoietic stem cell transplant (HSCT) recipients. Chimerix is preparing to initiate SUPPRESS, its Phase 3 study of CMX001 for the prevention of CMV infection in adult HSCT recipients, in 2013. The company has previously received Fast Track designation for its CMX001 development programs for preemptive treatment of adenoviral disease in patients post HSCT and for the treatment of smallpox.