Patients with lesions caused by herpes simplex virus have a new FDA-approved treatment option, an oral antiviral drug from Asahi Kasei.
The late Friday regulatory decision covers the treatment of adults whose lesions do not respond to the three oral antivirals that make up the current standard of case. Asahi Kasei’s once-daily pill, known in development as pritelivir, will be commercialized under the brand name Hovilpri.
In people with healthy immune systems, herpes simplex virus (HSV) infection is often asymptomatic or causes mild disease. But in people with weakened immune symptoms — those who have undergone a transplant procedure, or patients with HIV, cancer, or autoimmune disorders — HSV infection can occur more frequently and with greater severity. While oral antivirals are available to treat HSV, viral mutations can lead to resistance to these older drugs. There are alternative treatment options, but they require intravenous dosing.
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Hovilpri gives patients the choice of an oral drug with a different mechanism of action. This small molecule is designed to inhibit a complex of enzymes key to the synthesis of viral DNA. The drug was developed to treat both types of HSV, HSV-1 and HSV-2.
The regulatory submission for Hovilpri was based on the results of a Phase 3 study that showed statistically significant superiority in lesion healing up to day 28 compared to the physician’s choice of treatment. The most common adverse reaction reported for the study drug was headache.
“Today’s approval delivers the first FDA-approved treatment for refractory mucocutaneous HSV lesions with a novel mechanism of action in nearly 30 years and marks an important advancement for immunocompromised adults,” Stacy Wheeler, CEO of Asahi Kasei Therapeutics in the U.S. and Europe, said in a prepared statement. “Hovilpri offers a new oral treatment option for adult patients with a persistent, difficult-to-treat disease.”
Hovilpri was originally developed by AiCuris Anti-Infective Cures, a Germany-based biopharmaceutical company acquired by Asahi Kasei for €780 million (about $919 million). In the February acquisition announcement, Tokyo-based Asahi Kasei said the deal strengthens the company’s presence in severe infectious disease. It added that HSV patients addressed by Hovilpri are commonly seen in transplant centers and specialized hospital settings where the company has established commercial relationships and infrastructure.
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Asahi Kasei has been expanding its portfolio and pipeline via business deals. In 2020, the company closed the 8.3 billion Danish krone (about $1.3 billion) acquisition of Veloxis Pharmaceuticals, a company that develops and sells therapies for organ transplant patients. The Japanese company’s 11.8 billion Swedish krona (about $1.18 billion) acquisition of Calliditas Pharmaceuticals in 2024 brought a portfolio that includes Tarpeyo, which has FDA approval for treating the rare kidney disorder immunoglobulin A nephropathy.
The Aicuris acquisition brought more than Hovilpri. Asahi Kasei gains royalty income from Prevymis, a cytomegalovirus drug whose global rights Aicuris had licensed to Merck. The Japanese company also gets an experimental antisense oligonucleotide that Aicuris has advanced to Phase 1 testing as a treatment for BK virus infection in kidney transplant patients.
Photo by Asahi Kasei