FDA Grants Fast Track Status for Neovacs’ study of IFNα Kinoid in Lupus
The U.S. Food and Drug Administration (FDA) has granted Fast Track status to Neovacs’ IFNα Kinoid, which is being evaluated as a potential new treatment for lupus.
The IFNα-Kinoïd is an anti interferon alpha (IFNα) therapeutic vaccine. The vaccine is aimed at blocking interferon alpha, or IFNa, a protein linked to lupus.
Fast Track is a process designed by the FDA to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
“This Fast Track designation reinforces our confidence in the therapeutic potential of IFN Kinoid as a treatment for lupus,” said Therese Croughs, chief medical officer of Neovacs. “Today, the available treatments only aim to reduce the inflammation, to alleviate the symptoms and are associated with significant side effects.”
Neovacs is currently enrolling participants in its Phase IIb trail (IFN-K 002, ClinicalTrials.gov identifier: NCT02665364) for moderate to severe lupus.
For more information, read the Neovacs news release.