The ID Pipeline: FDA Activity From the Week of April 28, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 28, 2019.

NuGenerex Diagnostics Announces Sales of Rapid Point-of-Care Malaria Diagnostic Test Kit

On Thursday, May 2, 2019, Generex Biotechnology Corporation subsidiary NuGenerex Diagnostics LLC announced sales of its rapid point-of-care malaria diagnostic kit.

The company, which is fully qualified as a dianostics test developer and manufacturer under the FDA Good Manufacturing Procedures, filled an international order for 40,000 units of its NGDx -Malaria PF/PV Cassette Test Kit to Netherlands-based Imres, BV.

“This contract represents the first product sales for NuGenerex Diagnostics, and we hope to build on this foundation to capitalize on the World Health Organization authorization for the NGDx Test Kits for infectious diseases including HIV, Tuberculosis, Hepatitis B & C, and syphilis," Harold G. Haines PhD, president of NuGenerex Diagnostics, said in a press release. "At NGDx we are happy to be part of the ongoing effort by numerous private, governmental, and non-governmental international organizations to reduce the worldwide active burden of malaria and other transmissible infectious diseases by the use of our diagnostic tests. One of the goals of the World Health Organization is to eliminate malaria by 90% in affected countries by the year 2030. We are proud to be a supporter of, and a participant, in achieving that goal.”

Read the full press release here.

FDA Approves Dengvaxia Vaccine

On Wednesday, May 1, 2019, the FDA announced the approval of the vaccine Dengvaxia for the prevention of dengue disease in children aged 9 to 16 years with a laboratory-confirmed case of previous dengue infection. Eligible individuals must live in an endemic region of the US, which include American Samoa, Guam, Puerto Rico, and the US Virgin Islands.

Dengvaxia, produced by Sanofi Pasteur, is a live, attenuated vaccine, with an initial dose administered followed by 2 additional shots given 6 and 12 months later.

Dengvaxia is not approved for use in individuals who have not previously been infected by any serotype of dengue or for those without serological proof of illness. The reason behind this, according to the FDA, is that Dengvaxia "appears to act as a first dengue infection, without actually infecting the person with wild-type dengue virus — such that a subsequent infection can result in severe dengue disease."

Read the full story on the Dengvaxia approval here.

FDA Issues Complete Response Letter to Nabriva for Intravenous Fosfomycin

On Tuesday, April 30, 2019, the FDA issued a Complete Response Letter (CRL) to Nabriva Therapeutics for intravenous fosfomycin (Contepo) for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

According to a press release, the CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the New Drug Application. Nabriva plans to request a “Type A” meeting to discuss the FDA’s findings. The FDA did not request any new clinical data and did not raise any concerns with regard to the safety of Contepo.

“We will be working with the FDA in the coming weeks to gain a full understanding of the FDA’s comments, with the goal of bringing this important treatment to patients as quickly as possible,” Ted Schroeder, CEO of Nabriva Therapeutics, said in a statement.

Read the full story on the fosfomycin for injection CRL here.

InDevR Inc. Receives 510(k) Market Clearance for FluChip-8G Influenza A+B Assay

On Tuesday, April 30, 2019, the FDA granted 510(k) market clearance to InDevR Inc. for its FluChip-8G Influenza A+B Assay, which is the first cleared flu diagnostic able to characterize a wide variety of viruses as "non-seasonal." The FluChip-8G also has the ability to characterize seasonal viruses in a single multiplexed assay with same-day results.

"This is a tremendous accomplishment by the extraordinary team of scientists and engineers at InDevR," Dr. Nancy Cox, retired former director of the Influenza Division within the US Centers for Disease Control and Prevention, said in a press release. "I applaud their efforts to develop an in vitro diagnostic that can be used as an early warning system for the emergence of new strains of influenza."

Read the full press release here.

New Drug Application Submitted for Monthly Injectable 2-Drug Regimen for HIV

On Monday, April 29, 2019, ViiV Healthcare submitted a New Drug Application to the FDA seeking approval for the monthly injectable two-drug regimen of cabotegravir and rilpivirine for the treatment of HIV-1 infetion in adults whose viral load is suppressed.

The results of the global phase 3 ATLAS and FLAIR studies showed that a monthly injection of ViiV's cabotegravir and Janssen's rilpivirine was as effective as the daily, oral, 3-drug standard of care regimen in suppressing viral loads throughout the 48-week study period.

Read the full press release here.