Name: Hovilpri (pritelivir) in Refractory mucocutaneous herpes simplex virus infection in immunocompromised adults: Other product development or post-marketing obligations required by the FDA
Published: 2026-10-11T11:04:25-04:00

Postmarketing requirements and commitments in an FDA approval letter

No evidence found.

Nonclinical studies ongoing at approval: carcinogenicity

“Carcinogenicity studies with pritelivir are ongoing.” (opens the prescribing information at this quote)

Populations not evaluated at approval

“The safety and efficacy of HOVILPRI have not been established in pediatric patients 18 years of age and younger.” (opens the prescribing information at this quote)
“The pharmacokinetics and safety of pritelivir in patients requiring hemodialysis have not been evaluated” (opens the prescribing information at this quote)
“The pharmacokinetics and safety of pritelivir in patients with severe hepatic impairment (Child-Pugh Class C) have not been evaluated” (opens the prescribing information at this quote)
“There are no available data on HOVILPRI use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.” (opens the prescribing information at this quote)
“There are no data on the presence of pritelivir or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.” (opens the prescribing information at this quote)

European Union paediatric investigation plan: agreed measures

Area	Measure
Quality-related studies, Study 1	“Development of an oral suspension prepared from the film-coated tablets.”
Clinical studies, Study 2	“Open-label, multi-centre trial to assess the pharmacokinetics, safety and clinical activity of pritelivir (mesylate monohydrate) in immunocompromised paediatric patients from 6 years to less than 18 years of age with mucocutaneous herpes simplex infection (AIC316-03-P-01).”
Extrapolation, modelling and simulation studies, Study 3	“Modelling and simulation study to determine the dose pritelivir (mesylate monohydrate) to be used in immunocompromised children and adolescents from 6 years to less than 18 years of age with acyclovir-resistant mucocutaneous herpes simplex infection.”
Extrapolation, modelling and simulation studies, Study 4	“Extrapolation study, to evaluate the use of pritelivir (mesylate monohydrate) in paediatric subjects from 6 years to less than 18 years of age with acyclovir-resistant mucocutaneous herpes simplex infection.”

European Union paediatric investigation plan: completion date, deferral, and waiver

“Date of completion of the paediatric investigation plan: By February 2029” (opens the source at this quote in a new tab)
“Deferral for one or more measures contained in the paediatric investigation plan: Yes” (opens the source at this quote in a new tab)
“Concerns on potential long term safety/efficacy issues in relation to paediatric use: No” (opens the source at this quote in a new tab)
“the paediatric population from birth to less than 6 years of age;” (opens the source at this quote in a new tab)
“on the grounds that clinical studies with the specific medicinal product cannot be expected to be of significant therapeutic benefit to or fulfil a therapeutic need of the specified paediatric subset(s).” (opens the source at this quote in a new tab)
“From 6 to less than 18 years of age.” (opens the source at this quote in a new tab)

Field	Quoted record
Decision date	“29/10/2021”
Compliance check done	“No”

Further clinical trials: company statement, February 2026

“are there plans to conduct further clinical trials beyond the Phase 3 PRIOH-1 trial?” (opens the source at this quote in a new tab)
“we currently have no plans for additional clinical trials, but we will consider them as necessary.” (opens the source at this quote in a new tab)

Other product development: broader herpes simplex virus populations

“Line extension potential in an extended patient population” (opens the source at this quote in a new tab)

“Additionally, Aicuris' prior assumptions included sales potential from expanding the indication to a broader population of general HSV infection patients, whereas we calculated the market size primarily targeting immunocompromised patients.” (opens the source at this quote in a new tab)

“I hope that if the trial for acyclovir-resistant HSV goes well, we would be able to go back to the general population with further trials,” (opens the source at this quote in a new tab)