FDA Fast Track: Accelerating AlloNK's Development

In this Pharmaceutical Executive video interview, Fred Aslan, MD, CEO, Artiva Biotherapeutics, discusses the company’s current trials for autoimmune indications in the US. The first is a company-sponsored trial focusing on lupus, while the second is an investigator-initiated trial exploring four conditions: lupus, rheumatoid arthritis, pemphigus vulgaris, and vasculitis. This second trial is uniquely being conducted in a community setting to assess the practicality of outpatient treatment.

Pharmaceutical Executive: You've received FDA Fast Track designation for AlloNK in autoimmune diseases. How do you anticipate this designation will accelerate the development and potential approval of your therapy?
Fred Aslan: Fast Track designation indicates that FDA considers the therapy to be a novel therapy for an unmet need. There is a higher level of urgency for the agency, which allows for more prompt communication. Another advantage is that if you are approaching a market approval, it opens the optionality for you to have a rolling marketing application. This means that you can submit portions of your filings so the agency can start reviewing them earlier, as opposed to having to have your full dossier completed and then submitting it to FDA. It acknowledges that what you're doing has an important clinical unmet need, as well as increases your opportunities to interact with the agency to make progress a little faster.