USA – FDA finalizes guidance on drugs for cytomegalovirus in transplant patients

The US Food and Drug Administration (FDA) on Thursday finalized guidance on developing drugs to treat or prevent cytomegalovirus, a common virus in the beta-herpes virus group, in patients who have undergone solid organ (SOT) or hematopoietic stem cell transplantation (HSCT).

Cytomegalovirus, which is through to be present in 40-80% of the US population, is typically benign and self-limiting in patients with a normal immune system. However, the virus can cause complications and increased morbidity in patients with compromised immune systems, such as transplant recipients.

The 31-page final guidance lays out considerations for drugmakers looking to develop drugs to treat or prevent cytomegalovirus in transplant patients, from early-phase development through Phase 3 efficacy trials…