FDA approves first pill for stubborn herpes sores in frail patients
The FDA on Friday approved Hovilpri, a pill for herpes sores that won't heal with standard drugs in people with weak immune systems. In a 101-patient trial, 63% healed fully within 28 days, compared with 34% on other treatments. The maker estimates about 15,000 U.S. patients could use it.
The Food and Drug Administration on Friday approved a new pill for a hard-to-treat form of herpes.
The drug, Hovilpri, also called pritelivir, is for adults with weak immune systems who have herpes sores that did not get better with the usual antiviral drugs: acyclovir, valacyclovir or famciclovir. The sores can appear on the lips, nose, eyes or genitals.
Herpes simplex virus is common, and it cannot be cured. For most people, outbreaks come and go and respond to standard pills. But people with cancer, organ transplants, HIV or other conditions that weaken the immune system can have worse outbreaks. Sometimes the virus becomes resistant to the usual drugs, the FDA said.
Hovilpri works in a new way. It blocks proteins the virus needs to copy itself, Reuters reported. Older drugs must first be switched on by a viral enzyme, and mutations can stop that from happening.
The approval is based on a trial of 101 adults. Patients took Hovilpri or a doctor's choice of other treatments, including foscarnet, a drug given through a vein. After 28 days, all sores had healed in 63% of patients on Hovilpri, compared with 34% of those on other drugs, the FDA said. Patients take a 400-milligram first dose and then 100 milligrams a day, Contemporary OB/GYN reported.
The drug was developed by German company Aicuris, which Japan's Asahi Kasei bought in April. Asahi Kasei has estimated the pill could serve about 15,000 U.S. patients and bring in more than $400 million a year at its peak in the 2030s, Reuters reported.
The FDA gave the drug a priority review, a faster track for medicines that fill a major gap. Patients should check the label for drug interactions.
What we know: Hovilpri is approved for herpes sores that resist standard drugs in immunocompromised adults.
What we don't: The price, which has not been announced.
Where outlets agree Reuters and Contemporary OB/GYN both report the 101-patient trial behind the approval, with about 63% of Hovilpri patients fully healed by day 28 versus 34%.
Where they differ The outlets cited here report the same key facts so far.