US FDA approves Asahi Kasei's drug for persistent herpes infections

Oct 9 — The US FDA on Friday approved Japan's Asahi Kasei's ​drug for persistent herpes simplex virus sores in certain patients with weakened immune systems who have ‌not responded to available antiviral treatments.

• The oral drug, called pritelivir, ⁠was developed by German ​drugmaker Aicuris, which Asahi Kasei ⁠acquired in April

• Pritelivir blocks proteins the herpes ‌virus needs to ‌copy its genetic material, stopping it from multiplying ⁠and allowing the drug ⁠to work against some infections resistant to older treatments

• Older first-line drugs must be activated by a viral enzyme before blocking replication, and mutations that disrupt this activation can cause resistance

• The US Food ‌and Drug Administration's approval was ​based on a late-stage trial involving 101 participants, in which sores healed completely within 28 days in 62.7% of patients who were given pritelivir, compared to 34% receiving other treatments

• The trial compared pritelivir with doctors' choice of intravenous foscarnet, the main ​approved alternative, or cidofovir and imiquimod — older medicines used ‌off-label

• The commonly ‌reported ⁠side effects in the trial included headache, diarrhea, nausea, reduced appetite, vomiting and dizziness

• Asahi Kasei had previously estimated pritelivir could serve about 15,000 US patients with ‌weakened immune systems, and ​generate peak annual sales ‌of more than $400 million ⁠in ​the mid-to-late 2030s

(Reporting by Kunal Das in Bengaluru; Editing by ​Shilpi Majumdar)

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