News Scan for Dec 12, 2017

Smallpox drug review
Flu rise in North America, Asia
Cholera in Kenya, Zambia

SIGA requests priority FDA review of its oral smallpox drug

SIGA Technologies of New York City announced yesterday that it has submitted its smallpox drug TPOXX (tecovirimat) for priority review by the US Food and Drug Administration (FDA).

If approved, the oral drug would be the first FDA-approved treatment for smallpox, a disease that has been eradicated but could be used as a bioterror weapon. The news comes on the heels of media reports that North Korea could be building a bioweapons program that might include smallpox.

TPOXX was developed to treat smallpox and other orthopoxvirus infections. SIGA has successfully delivered two million courses of TPOXX to the Strategic National Stockpile. No cure for smallpox currently exists, but lab personnel who work with smallpox or related viruses receive vaccination as a preventive measure.

SIGA CEO Phil Gomez, PhD, said in a news release, "Based on extensive positive efficacy data in animal studies and human clinical safety data without any drug-related serious adverse events, we believe the NDA [new drug application] for oral TPOXX is well positioned for favorable, expedited review by the FDA."

SIGA expects to receive notification from the FDA in February 2018 that its filing was accepted for review, as well as confirmation of priority review status and notification of a final action date.
Dec 11 SIGA news release
Dec 11 CIDRAP News scan on North Korea bioweapons


WHO: Flu on the rise in North America, parts of Asia

The World Health Organization (WHO) released a new global influenza update yesterday, showing that influenza is on the rise in North America, Western and Central Asia, and Europe.

In North America, the predominant strain has been influenza A, H3N2. Europe, however, has more influenza B circulating at this time. Both influenza A and B have been detected in Asia. In Western Africa, influenza A (H1N1) detections increased in Cote d'Ivoire and Ghana. Influenza B detections were reported in Central African Republic and Mozambique.

The temperate zones of South America continue to report low influenza-like illness (ILI) activity. The Caribbean and Central America also report low ILI activity.

Canada, the United States, and Mexico have all crossed the seasonal threshold for ILI. Adults over 65 have accounted for most influenza cases in the United States and just under half in Canada.

Worldwide, laboratories reporting to the WHO have typed 62.5% of viruses as influenza A and 37.5% as influenza B.
Dec 11 WHO update


Cholera outbreaks reported in Kenya, Zambia

Yesterday the WHO reported two outbreaks of cholera in Kenya and Zambia, with the Kenyan outbreak involving nearly 4,000 cases.

Between Jan 1 and Nov 29, Kenyan officials have reported 3,967 probable and confirmed cases of cholera, including 76 deaths. Transmission has been linked to camps, institutions, and mass gatherings. Community transmission is still ongoing in 7 Kenyan counties as of Nov 29, but 20 of 47 counties (43%) in the country have documented cholera cases this year.

The WHO said the risk of widespread transmission in Kenya is high. "Despite the decline in the number of cases reported, the outbreak appears to be clustered around two major types of settings. First, the refugee camps particularly Kakuma and Dadaab, and second in the populous Nairobi capital county," the WHO explained.

In Zambia, officials have reported 547 cases and 15 deaths since late September. Most cases are in the capital of Lusaka. The districts where cases have been documented have poor sanitation and water supply. A recent influx of refugees from the Democratic Republic of the Congo and the upcoming rainy season mean there's a strong chance the outbreak will grow in the coming months, the WHO said.
Dec 11 WHO Kenya report
Dec 11 WHO Zambia report

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