FDA Delays Nabriva Approval, Citing Inability to Conduct Inspections Amid COVID-19

The infectious disease pharmaceutical and medical device pipeline is always evolving. See below for a round-up of our FDA drug pipeline coverage from the past week:

Nabriva Therapeutics Receives CRL FDA Letter Delaying Approval

Ireland-based Nabriva Therapeutics announced it received a complete response letter (CRL) from the US Food and Drug Agency (FDA) regarding its anti-infective agent fosfomycin. The company is seeking FDA approval for injection for complicated urinary tract infections (cUTI), including acute pyelonephritis.

In the CRL, the FDA sited its inability to conduct inspections at the company’s manufacturing facilities due coronavirus 2019 (COVID-19)-related travel restrictions. The FDA also pointed out it was not looking for any additional data related to fosfomycin’s efficacy or safety.

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FDA Authorizes 15-Minute Antibody Testing Kit

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Virtality Diagnostics for a rapid coronavirus 2019 (COVID-19) antibody test which detects both IgG and IgM antibodies with 98.5% accuracy.

The diagnostic test, which requires a drop of blood from a finger prick, delivers results in 15 minutes, according to the company.

As an antibody test, it is capable of measuring the body’s immune response and determining whether a person’s body produced an antibody response to SARS-CoV-2 infection—indicating both past exposure to and infection by novel coronavirus.

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HHS to Receive $32M Worth of Smallpox Drug

The Department of US Health and Human Services (HHS) will soon receive roughly $32 million worth of oral tecovirimat from SIGA technologies, according to a SIGA press release.

“SIGA is pleased to continue to deliver tecovirimat to HHS to ensure robust preparedness for a potential smallpox outbreak,” said Phil Gomez, PhD, CEO of SIGA Technologies, in the press release. “As the ongoing COVID-19 pandemic has demonstrated, preparing in advance to address potential biologic threats is essential for rapid and effective response. Maintaining a supply of treatments, like TPOXX, to combat smallpox is part of a long-standing global commitment to a smallpox emergency response. Smallpox remains one of the most horrific and devastating diseases ever known.”

While smallpox may not be in headlines today, the illness (treated with tecovirimat) remains a threat. Given the ongoing coronavirus pandemic, maintaining medical supply-side preparedness is seen in a new and more urgent light.

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