Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

VIITAL: A Phase 3 Study of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Next Previous
Trial Profile

VIITAL: A Phase 3 Study of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Apr 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Prademagene zamikeracel (Primary)
  • Indications Epidermolysis bullosa dystrophica
  • Focus Registrational; Therapeutic Use
  • Acronyms VIITAL; VITAL
  • Sponsors Abeona therapeutics

    • Most Recent Events

    • 22 Apr 2024 According to an Abeona Therapeutics media release, Company submitted plans to the FDA with the commitment to provide CMC data prior to BLA approval, anticipate completing the BLA resubmission in the third quarter of 2024 with necessary updates to fully satisfy all the deficiencies outlined in the CRL.
    • 22 Apr 2024 According to an Abeona Therapeutics media release, The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Companys Biologics License Application (BLA) for pz-cel,The CRL follows the completion of Abeonas Late Cycle Review Meeting with the FDA in March 2024.
    • 18 Mar 2024 According to an Abeona Therapeutics media release, the FDA has completed the clinical study site inspections of Stanford University School of Medicine in Palo Alto, CA and University of Massachusets Medical School in Worcester, MA, both of which enrolled subjects in the pivotal Phase 3 VIITAL™ study supporting the pz-cel BLA, with no Form 483 observations noted
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top