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FDA Grants Fast Track Designation for CMX001 for Prevention of Cytomegalovirus Infection
The FDA has granted Fast Track designation for CMX001 (Chimerix, Inc.) for the prevention of cytomegalovirus (CMV) infection. CMX001 is a broad-spectrum, oral nucleotide analog lipid-conjugate that blocks the replication of double-stranded DNA viruses, including CMV, adenovirus, BK virus (a human polyomavirus), and herpes simplex virus.
The FDA’s Fast Track program is designed to 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.
CMX001 has completed phase II clinical development for the prevention of CMV infection in adult hematopoietic stem-cell transplant (HSCT) recipients. SUPPRESS, a phase III trial of CMX001 for the prevention of CMV infection in adult HSCT recipients, is scheduled to begin in 2013. An additional phase II study is evaluating CMX001 as preemptive therapy for adenovirus disease — an often-fatal infection that has no approved therapies — in HSCT recipients.
Source: Chimerix Inc.; March 12, 2013.