US FDA approves Asahi Kasei’s drug for persistent herpes infections
The US Food and Drug Administration (FDA) recently green-lit Japan's Asahi Kasei's pritelivir drug for treating persistent herpes simplex virus sores in certain patients with compromised immune systems who have not seen improvement from existing antiviral therapies.
The oral medication, created by German pharmaceutical firm Aicuris, which Asahi Kasei acquired in April, functions by obstructing essential viral proteins crucial for the herpes virus to replicate its genetic material. By inhibiting replication, the drug effectively combats infections resistant to conventional treatments.
The FDA's approval hinged on a late-stage clinical trial featuring 101 participants. The study revealed that sores healed completely within 28 days in 62.7% of patients administered pritelivir, compared to just 34% receiving alternative treatments. The trial pitted pritelivir against doctors' preferred intravenous foscarnet, the primary approved alternative, or cidofovir and imiquimod, older medications often used off-label.
Most frequent adverse effects reported during the trial included headache, diarrhea, nausea, decreased appetite, vomiting, and dizziness. Asahi Kasei had previously projected that pritelivir could cater to approximately 15,000 US patients with weakened immune systems, potentially generating peak annual sales surpassing $400 million in the mid-to-late 2030s.
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