Flu drug receives expanded approval for use in high-risk patients
The Food and Drug Administration (FDA) approved the use single-dose Xofluza (baloxavir marboxil) for patients ages 12 and over who are at high risk for influenza complications. Xofluza should only be administered to patients who have been symptomatic for 48 hours or less.
"With the flu season rapidly approaching, we can now offer Xofluza as the first and only FDA-approved treatment option indicated specifically for those at high risk of flu complications," said Levi Garraway, MD, PhD, the chief medical officer and head of global product development for Xofluza's manufacturer, Genentech.
"People with chronic conditions such as asthma, heart disease, and diabetes are at higher risk of developing serious complications from the flu, so it is critical that these patients speak with their healthcare providers about possible treatment at the first signs and symptoms of the disease," Garraway said in a press release.
The expanded approval was based on results from the Phase 3 CAPSTONE-2 study of a single dose of 40 mg or 80 mg of Xofluza compared to oseltamivir (75 mg twice daily for 5 days), or placebo in people 12 years of age or older and were at high-risk for flu complications, Genentech said.
In October 2018, the FDA approved Xofluza for the treatment of acute, uncomplicated flu in otherwise healthy people 12 years of age and older. Xofluza's approval represented the first new antiviral to treat the flu in the United States in 20 years.
Oct 17 Genentech press release
Early results promising for universal flu vaccines targeting HA stalk
A phase 1 clinical trial that assessed different chimeric hemagglutinin-based universal flu vaccine regimens found that all prompted cross-reactive serum immunoglobulin G (IgG) antibodies targeting the conserved stalk region. A team led by researchers at the Icahn School of Medicine at Mount Sinai published their findings yesterday in The Lancet Infectious Diseases.
The stalk portion of the flu virus's hemagglutinin protein is more conserved than the more variable head portion and has been a target for the development of better and more broadly protective flu vaccines.
For the study, researchers looked at several chimeric hemagglutinin (cHA)-based vaccination regimens to see if they would trigger antibodies that would broadly protect against flu. The regimens included a chimeric H8/1 HA-based live-attenuated vaccine followed by a nonadjuvanted H5/1 HA-based inactivated vaccine (IIV), the same regimen but with an AS03-adjuvanted IIV boost, and a prime-boost regimen including an adjuvanted cH8/1 IIV prime followed by an adjuvanted cH5/1 IIV boost.
The study took place between Oct 10, 2017, and Nov 27, 2017, among 65 healthy adults in two US centers. Participants were randomly assigned to one of three prime-boost regimens or one of two placebo groups.
After the priming dose, the adjuvanted IIV, but not the live-attenuated vaccine, prompted a substantial IgG antibody response, resulting in a seven times higher increase in anti-H1 stalk antibody titers on day 29. After the booster doses, all vaccine regimens produced detectable anti H1 stalk antibodies, cross-reactive serum antibodies, and peripheral blood permablast responses. Regarding safety, the team found that the regimens were tolerable with no safety concerns.
Florian Krammer, PhD, a study coauthor who is with the department of microbiology at Mount Sinai, said in a press release from the school that the vaccine produced a broad antibody response, not only against currently circulating human flu viruses but also against avian and bat subtypes. "It was surprising to find that the inactivated formulation with adjuvant induced a very strong anti-stalk response already after the prime suggesting that one vaccination might be enough to induce protection against pandemic influenza viruses yet to arise," he said.
He said the results signal progress toward a universal flu vaccine, but the results are interim, with more results expected after the study is completed at the end of 2019.
Oct 17 Lancet Infect Dis abstract
Oct 17 Mount Sinai press release
WHO adds details on Saudi MERS cases recorded in September
Today the World Health Organization (WHO) published new details about the four MERS-CoV cases recorded in Saudi Arabia in September. The cases were reported from Al Qassim (2 cases), Riyadh (1 case), and Al Ahsa (1 case) regions.
None of the cases were secondary case contacts or healthcare workers. All four case-patients were men, with ages ranging from 39 to 74. Only one patient, the man from Al Ahsa, had camel exposure, which included drinking camel milk. Camel exposure has regularly been linked to Middle East respiratory syndrome (MERS-CoV) infections.
The oldest patient, a 74-year-old man from Al Qassim died within 10 days of symptom onset.
From 2012 through Sep 30, 2019, the total number of laboratory-confirmed MERS-CoV infection cases reported globally to WHO is 2,468, with 851 associated deaths. Saudi Arabia has had most of the cases.
Oct 18 WHO update
