Flu Scan for Jun 27, 2018

FDA priority review for new flu drug
Southern Hemisphere flu rise
Avian flu outbreaks in poultry

Novel one-dose antiviral receives FDA priority review

The US Food and Drug Administration (FDA) has granted fast-track approval for a new oral antiviral with a different mechanism of action than neuraminidase inhibitors that offers one-dose treatment, according to a Jun 25 statement from Genentech, part of the Roche Group. The drug, called baloxavir marboxil, was approved in Japan in February for the treatment of influenza A and B in adult and pediatric patients.

Called Xofluza in Japan, the drug is an endonuclease inhibitor that blocks viral replication by inhibiting cap-dependent endonuclease activity of the viral polymerase, a process known as "cap snatching." The drug is designed to target oseltamivir-resistant strains and avian flu viruses including H5N1 and H7N9. Clinical studies have found that baloxavir marboxil and oseltamivir similarly reduce symptom duration and fever, but that the new drug more quickly stopped viral shedding.

Sandra Horning, MD, Genentech's chief medical officer and head of global product development, said, "The severity of the recent flu season underscores the need for new options beyond currently available treatments, and if approved, baloxavir marboxil would be the first flu medicine with a novel proposed mechanism of action in nearly 20 years."

The indication the FDA is considering is for acute uncomplicated flu in people ages 12 and older, and the company said a regulatory decision is expected by Dec 24, 2018. A phase 3 trial of the drug is underway in people ages 12 and older who are at high risk of flu complications. The drug was developed by Japan-based Shionogi and is being developed by Roche Group, which holds worldwide rights, excluding Japan and Taiwan.
Jun 25 Genentech press release


Seasonal flu on the rise in some Southern Hemisphere locations

Influenza levels are on the rise in some parts of the Southern Hemisphere, including South Africa and tropical countries in the Americas, but activity remains under seasonal thresholds in other countries in the region, the World Health Organization (WHO) said in its latest global flu update.

In South Africa, 2009 H1N1 is the predominant virus, though Brazil is reporting increasing detections of both 2009 H1N1 and H3N2. Elsewhere in South America, flu levels varied by country, with 2009 H1N1 and influenza B increasing in temperate parts of Bolivia and 2009 H1N1 illnesses increasing in Peru. Flu in Australia and New Zealand remained at interseasonal levels, with New Caledonia continuing to report influenza B activity.

Countries in southern Asia reported low levels, except for the Maldives, which reported a sharp increase in H3N2 activity in recent weeks. In Northern Hemisphere temperate zone countries, flu activity returned to interseasonal levels.

Globally, of specimens tested between May 28 and Jun 10, 71.1% were influenza A and 28.9% were influenza B. Of subtyped influenza A viruses, 72.8% were 2009 H1N1 and 27.2% were H3N2. Of the characterized influenza B viruses, 74% belonged to the Yamagata lineage.
Jun 25 WHO global flu update


Bulgaria, Russia, and Taiwan report more high path avian flu in poultry

In the latest avian flu developments, three countries—Bulgaria, Russia, and Taiwan—reported more outbreaks involving different strains, according to the latest notifications from the World Organization for Animal Health (OIE).

Bulgaria, which has been reporting sporadic highly pathogenic H5N8 outbreaks since early March, reported an event that began on Jun 13 at a poultry farm in Dobric, located in the northeastern part of the country. The virus killed 1,715 of 13,820 poultry, and the surviving birds were culled to control the spread of the disease.

In Russia, the agriculture ministry reported 11 more outbreaks involving highly pathogenic H5 from four different oblasts in the country's west: Samarskaya, Saratovskaya, Orlovskaya, and Penzenskaya. The outbreaks began between Jun 8 and Jun 21, and all involved backyard poultry. Taken together, the virus killed 122 of 2,167 birds, and authorities destroyed the survivors as part of the outbreak response.

Elsewhere, Taiwan reported two more outbreaks from highly pathogenic H5N2, part of ongoing activity involving that and other strains since 2015. The two new events began between Jun 21 and Jun 22, and both involved meat duck farms in Yunlin County. Between the two locations, the virus killed 400 of 6,607 birds, and the remaining ones were culled.
Jun 24 OIE report on H5N8 in Bulgaria
Jun 27 OIE report on H5 in Russia
Jun 27 OIE report on H5N2 in Taiwan

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