March 16, 2020
The Lupus Research Alliance is pleased to share an announcement from Aurinia Pharmaceuticals that moves its potential treatment for lupus nephritis, voclosporin, one step closer to approval by the U.S. Food and Drug Administration (FDA). The Company announced in a press release March 16 that it has started a Rolling Submission of its New Drug Application (“NDA”) to the FDA.
The NDA application is the way drug sponsors formally propose that the FDA approve a new pharmaceutical treatment for sale and marketing in the U.S. According to the FDA, “The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.” The rolling NDA allows portions of the application to be submitted and reviewed by the Agency on an ongoing basis.
The FDA explains: “The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:
- Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
- Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain.
- Whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.
The documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.”
Aurinia has submitted the portion of the application called Nonclinical Module and expects to submit all Modules by the end of the second quarter of 2020.