The FDA Found Issue With Several NDAs in 2020, Partly Due to the COVID-19 Pandemic

COVID-19’s tentacles have invaded the New Drug Applications (NDAs) for 2020. A recent article in Fierce Pharma reported that the FDA has been especially vigilant in scrutinizing NDAs this year, but we do have COVID-19 preventing onsite inspections and travel.

About Sanofi’s Drug Sutimlimab

In terms of Sanofi’s drug sutimlimab, which treats rare blood diseases, the issue, according to the FDA, was “certain deficiencies.” The deficiencies that caused a temporary halt in Sanofi’s NDA were found at a contractor’s manufacturing facility. However, the FDA’s letter did not take issue with sutimlimab’s clinical findings or its safety.

When contacted for this article, Sanofi’s spokesperson would not divulge the name of the contractor or the deficiencies.

Resolving the Issues

Sanofi notified the FDA that it will cooperate with the agency and coordinate with the manufacturer to see that the issues are resolved as quickly as possible.

Prior to the FDA notification, sutimlimab was slated to receive the FDA’s decision on November 13, 2020. The FDA had previously granted priority review to Sanofi as a result of its phase 3 data showing thirteen of the twenty-four patients who received sutimlimab therapy met the study’s endpoint.

Also, the drug would have been the only approved treatment for a rare blood disease called cold agglutinin disease (CAD).

About Nabriva’s Drug Contepo

In June of 2020, the FDA sent its second letter to Nabriva regarding its antibiotic Contepo (a/k/a fosformycin), citing problems at one of the company’s contract manufacturing locations in Europe.

Although in this case, Nabriva answered back stating that the problems had been solved, but due to COVID travel restrictions, the FDA was precluded from traveling to the plant.

Nabriva said that without FDA on-site inspections, it could not verify that it had indeed remedied the issues set out in the FDA’s initial letter.

About Spectrum’s Rolontis

Another COVID-19 casualty is the drug Rolontis, developed by Spectrum. As of October 2020, its application was delayed due to a letter from the FDA citing its inability to travel to South Korea for on-site inspections due to travel restrictions.

With a coordinated effort, the COVID-19 related issues concerning the FDA’s Complete Response Letters may hopefully be resolved.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia four years ago. He was treated with a methylating agent While he was being treated with a hypomethylating agent, Rose researched investigational drugs being developed to treat relapsed/refractory AML.

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