Investigational drug for resistant TB gets favorable FDA committee vote
An investigational drug to treat highly resistant strains of tuberculosis (TB) took another step in the regulatory approval process yesterday.
According to a news release from TB Alliance, the US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee voted yesterday that there is substantial evidence of the effectiveness and sufficient evidence of the safety of pretomanid as part of a combination treatment for adults with extensively drug-resistant (XDR), multidrug-resistant (MDR), or treatment-intolerant or nonresponsive TB. The oral regimen, known as BPaL, also includes bedaquiline and linezolid.
TB Alliance, which developed pretomanid, submitted a new drug application to the FDA in March and was granted priority review, a designation that speeds up the review process.
The committee's 14-4 vote, which is non-binding but will be taken into consideration by the FDA in its evaluation of the drug, was based on a review of safety and efficacy data from 19 clinical studies. Among those was the phase 3 Nix-TB trial, which tested the regimen in patients with XDR-TB and treatment-intolerant or non-responsive MDR-TB. An interim analysis found a favorable outcome in 90% of patients after 6 months of treatment and 6 months of follow-up.
"We are encouraged by the advisory committee's vote in favor of pretomanid for use in combination with bedaquiline and linezolid for the treatment of highly-resistant forms of TB and we look forward to the FDA's final action," Mel Spigelman, MD, president and CEO of TB Alliance, said in the release.
The FDA is expected to make a final decision on regulatory approval in August.
Jun 6 TB Alliance press release
Four new polio cases recorded in 3 countries
Three countries recorded four new polio cases total, according to a weekly update today from the Global Polio Eradication Initiative (GPEI).
Afghanistan has a new wild poliovirus type 1 (WPV1) case, Pakistan has two WPV1 cases, and Niger has one circulating vaccine-derived poliovirus type 2 (cVDPV2) case. The case-patient in Afghanistan experienced symptom onset on May 8; this is Afghanistan's eighth WPV1 case this year. In Pakistan, onset of paralysis for cases began on May 14 and 19, and the new cases raise the total for 2019 to 21.
The GPEI said the case in Niger is genetically linked to the ongoing outbreak of cVDPV2 in Jigawa, Nigeria. The case-patient in Niger experienced an onset of paralysis on Apr 3. This is the first cVCPV2 case reported in Niger in 2019; in 2018, the country saw 10 cases.
In addition to the new cases, officials recorded several environmental detections this week, according to the GPEI, including 16 positive WPV1 samples collected in Pakistan and one cVDPV2 sample in Nigeria.
The World Health Organization (WHO) yesterday also confirmed a positive cVDPV2 sample detected in a hospital in Cameroon on May 23. The sample is linked to the outbreak in Nigeria.
"This event highlights the risk of renewed international spread of cVDPV2 from Nigeria and the rest of the Lake Chad region, given the large-scale population movement; subnational immunity and surveillance gaps across the Lake Chad region," the WHO said.
Jun 7 GPEI update
Jun 6 WHO report
CDC warns of tuberculin test shortage
The US Centers of Disease Control and Prevention (CDC) said it expects a 3- to 10-month national shortage of Aplisol tests, manufactured by Par Pharmaceuticals. Aplisol is one of two purified-protein derivative (PPD) tuberculin antigens licensed for performing tuberculin skin tests, the CDC said in a Health Alert Network report yesterday.
Par Pharmaceuticals notified the CDC that it expects a shortage of 5-milliliter tests in June and of 1-milliliter tests in November.
"The 3-10 month timeframe for the nationwide shortage is the manufacturer's current estimate and is subject to change," the CDC said.
Tuberculin skin tests (TSTs) are one of two tests used to detect latent Mycobacterium tuberculosis infection. The CDC recommends that clinicians prioritize use of TSTs on patients most at risk for tuberculosis, and also to consider testing for the bacterium with interferon-gamma release assay (IGRA) blood tests.
Jun 6 CDC report
Officials confirm avian flu outbreaks in Mexico, South Africa
Highly pathogenic avian flu has struck poultry in Mexico and a commercial ostrich farm in South Africa, according to new World Organization for Animal Health (OIE) reports posted this week.
Mexican officials yesterday confirmed four H7N3 avian flu outbreaks in two backyard flocks and two farms in Guerrero, Queretaro, and Hidalgo states in south central Mexico. The outbreaks, which began from May 8 to May 20, affected backyard flocks of 25 and 54 birds and farms housing 1,300 and 133,566 poultry.
Among the four outbreaks the virus killed 1,160 birds, and officials disposed of the surviving poultry to curb further transmission. Officials also established quarantines and restrictions on the movement of poultry in and out of the affected areas.
The South African outbreak began on Apr 15 in Eastern Cape province in the south and sickened 22 ostriches on a farm containing 709 birds. It involved highly pathogenic H5N8 strain, and response measures include destroying animal products, by-products, and waste, as well as disinfection.
Jun 6 OIE report on H7N3 in Mexico
Jun 4 OIE report on H5N8 in South Africa