The ID Pipeline: FDA Activity From the Week of December 22, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of December 22, 2019.

Nabriva Therapeutics Resubmits New Drug Application for Intravenous Contepo to FDA

Nabriva Therapeutics plc, a biopharmaceutical company engaged in the development of anti-infective agents, announced that it has resubmitted its New Drug Application (NDA) to the FDA for Contepo (fosfomycin) for injection for the treatment of complicated urinary tract infections, including acute pyelonephritis. Nabriva estimates a 6-month review period.

The NDA for Contepo was resubmitted based on a Type A meeting with the FDA, which took place to clarify the Complete Response Letter (CRL) issued by the FDA in April 2019. The CRL stated that the FDA was unable to approve the NDA based on issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers. The FDA did not request new clinical data or raise any concerns with regard to the safety of Contepo.

Read the full press release here.

FDA Declines to Approve Cabotegravir/Rilpivirine

ViiV Healthcare has announced the receipt of a complete response letter (CRL) from the FDA for its new drug application for cabotegravir and rilpivirine long-acting injectable to treat HIV-1 in virologically suppressed adults.

Cabotegravir is an integrase strand transfer inhibitor developed by ViiV Healthcare and rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences. The cabotegravir and rilpivirine long-acting regimen is investigational and is not approved anywhere in the world.

According to the company, the reasons given in the CRL relate to chemistry manufacturing and controls. However, ViiV reports that there have been no reported safety issues related to chemistry manufacturing and controls and that there is no change to the safety profile of the products used in clinical trials to date.

In April, the FDA accepted the new drug application for the product.

Read the full article here.