The ID Pipeline: FDA Activity From the Week of September 8, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of September 8, 2019.

Nabriva's Lefamulin Now Available in United States

On Monday, September 9, 2019, Nabriva Therapeutics announced that oral and intravenous (IV) Xenleta (lefamulin) is available in the United States following FDA approval last month.

Both formulations were approved for the treatment of community-acquired bacterial pneumonia (CABP).

“The lack of innovative treatment options for CABP over the past two decades has resulted in increasing resistance in the most common bacteria causing CABP to multiple classes of antibiotics,” Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics, said in a statement. “These drug-resistant pathogens are undermining clinicians’ ability to fight CABP and we are delighted to announce that XENLETA is now available as a short course, empiric monotherapy treatment option for adults with CABP."

The full press release is available here.

FDA Grants Fast Track Status to IV and Oral Fosmanogepix

On Monday, September 9, 2019, the FDA granted fast track status to Amplyx Pharmaceuticals for intravenous and oral formulations of Fomanogepix (APX001) for 7 indications.

These indications include treatment of: invasive candidiasis, invasive aspergillosis, scedosporiosis, fusariosis, mucormycosis, cryptococcosis, and coccidioidomycosis.

"The FDA Fast Track designation for fosmanogepix is an important step forward in addressing the need for new medicines to treat fungal infections," said Ciara Kennedy, PhD, president and CEO of Amplyx, in a statement. "With fosmanogepix and its novel mechanism of action and robust clinical program, we are directly addressing the threat of invasive fungal infections by developing innovative therapies for immunocompromised patients who need them the most. We look forward to working closely with the FDA as we continue to advance fosmanogepix through clinical development."

The full press release is available here.