The ID Pipeline: FDA Activity From the Week of November 17, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of November 17, 2019.

Aztreonam and Avibactam Receive FDA Qualified Infectious Disease Product Designation and Fast Track Designation

The US Food and Drug Administration (FDA) has granted Allergan Qualified Infectious Disease Product Designation and Fast Track Designation for ATM-AVI (aztreonam and avibactam), for treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

ATM-AVI is an investigational, fixed-dose, intravenous combination antibiotic under development. The new designation provides incentives for the development of antibiotics, such as priorit review and a five-year regulatory exclusivity extension.

Read the full press release here.

ViiV Healthcare Obtains Exclusive Licensing Agreement With NIH Concerning Investigational bNAb N6LS For Treatment and Prevention of HIV

ViiV Healthcare announced that the company has obtained an exclusive licensing agreement for the development of the investigational broadly neutralizing antibody (bNAb) N6LS. The agreement was made between GSK, which is the majority owner of ViiV Healthcare, and the National Institute of Allergy and Infectious Disease (NIAID), which is a part of the National Institutes of Health (NIH).

N6LS was originally discovered by scientists at NIAID, and could serve as a next generation treatment regimen for people living with HIV.

Read the full press release here.

FDA Approves HCV Supplemental Labeling For Harvoni

The FDA has informed Gilead Sciences of approval for their supplemental new drug applications concerning Harvoni, a drug containing both ledipasvir and sofosbuvir.

The new drug applications provide for the use of Harvoni for the treatment of chronic hepatitis C virus infection in patients with severe renal impairment, including patients with end stage renal disease who are on dialysis.

Read the full letter here.