U.S. FDA seeks input on new uses for approved drugs

The U.S. Food and Drug Administration said Monday it is seeking public input on using approved drugs for new purposes across a range of diseases and conditions.

The agency said it wants feedback on possible new uses for FDA-approved drugs, including new disease indications or use in new patient groups, to help speed treatment availability by building on existing knowledge about those medicines.

The FDA said it is seeking information from patients, clinicians, researchers, and others on priority disease areas and possible drug candidates for repurposing, particularly where data supports new uses but incentives to seek approval are limited.

The agency said it is especially interested in input on metabolic diseases, neurodegenerative conditions, women’s and men’s health conditions, substance use disorders, and rare diseases.

It also asked for information on drug candidates with promising preliminary clinical data, including case reports and findings from artificial intelligence, that may warrant further study.

Fifteen passengers evacuated from the MV Hondius were admitted Monday to the quarantine unit at the University of Nebraska Medical Center, and one passenger who tested positive for hantavirus was placed in the biocontainment unit, officials said. Two other U.S. passengers were flown to Atlanta for “further assessment and care,” officials said.

Officials said 18 U.S. residents were repatriated from the cruise ship after passengers began disembarking Sunday in Tenerife, in Spain’s Canary Islands. Sixteen went to Nebraska. Of those, one person who tested positive was placed in biocontainment, and 15 who did not test positive were placed in quarantine. The other two were taken to Emory University’s Serious Communicable Diseases Unit in Atlanta, where officials said they were under medical evaluation. At least one of the two had symptoms.

The total number of confirmed and probable hantavirus cases linked to the ship rose to 10, officials said. That included two confirmed deaths and one death that remained under investigation as a suspected hantavirus case. Officials said one American and one French passenger tested positive after leaving the ship.

Dr. Mike Waldman, medical director of Nebraska’s quarantine unit, said the 15 people there were in “good spirits.” He said, “We’ve been doing symptom monitoring, as well as temperature checks. Everyone here is asymptomatic and … do not have a temperature at this time.” Officials said the person in biocontainment had no symptoms but was “very tired” after the trip.

The Department of Health and Human Services said the risk to the public remained low. Dr. Brian Christine, the department’s assistant secretary for health, said the Andes variant “does not spread easily, and it requires prolonged, close contact with someone who is already symptomatic.” Spanish Health Minister Monica Garcia said initial genetic analysis identified the virus as the Andes variant and found no relevant mutations.

Officials also said nine U.S. cruise passengers who left the ship before the outbreak was identified were being monitored by state health departments, and two more Americans exposed during air travel were in New Jersey. In France, Health Minister Stephanie Rist said one of five French evacuees tested positive, and 22 contact cases were isolating after exposure on two flights.

A French woman and an American man tested positive for hantavirus after countries repatriated passengers from the MV Hondius cruise ship, where an outbreak has been reported.

French Health Minister Stephanie Rist said Monday that a French passenger who had been on the ship tested positive and that her condition was deteriorating.

Four other French passengers tested negative, and authorities identified 22 contact cases.

The U.S. Department of Health and Human Services said Sunday that an American on a repatriation flight tested “mildly positive” for the virus and another person had mild symptoms. Both were traveling “in the plane’s biocontainment units out of an abundance of caution,” and all 17 MV Hondius passengers on board would undergo clinical assessment on arrival in the United States.

The MV Hondius was anchored near Tenerife in the Canary Islands after being stranded for weeks following the outbreak. Health authorities have been locating and monitoring passengers who left the ship before the outbreak was identified.

On Monday, 54 passengers and crew remained aboard. Of those, 22 were expected to disembark, while 32 were to remain on the ship as it returned to the Netherlands.

Spanish Health Minister Monica Garcia said a Dutch plane due to arrive in Tenerife on Monday afternoon would carry passengers who had previously been scheduled to depart on a flight operated by Australia.

Hantaviruses can cause severe respiratory illness. They are usually spread by rodents, but in rare cases can be transmitted between people. Symptoms can begin one to eight weeks after exposure and include headaches, fever, chills, gastrointestinal problems, and respiratory distress.

The Andes strain identified in the outbreak can have a fatality rate of 40 to 50%, particularly among older people. The WHO recommended a 42-day quarantine for cruise passengers.