FACTS:
- The FDA licensed Ezplaz Freeze Dried Plasma (FDP), the first freeze-dried plasma product licensed for use in the United States.
- Ezplaz is intended for transfusion in adult patients who need plasma when other plasma products are not available.
- Ezplaz is derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments and is available in Group AB and Group A with low-titer anti-B blood types.
- Unlike conventional plasma products that must be stored frozen and thawed, Ezplaz can be stored at room temperature, is stable after temperature fluctuations, and is rapidly reconstituted.
- Ezplaz is packaged in a plastic bag rather than a glass bottle, reducing the risk of breakage during handling and transport.
- Each Ezplaz kit contains one unit of freeze-dried plasma sealed in an outer foil pouch, one 250 mL bag of sterile water for injection, one sterile fluid transfer set, and one sterile blood transfusion set.
- Ezplaz is indicated for transfusion in adults including bleeding patients, patients needing massive transfusion, or certain patients on warfarin who are bleeding.
- Freeze-dried plasma was among the first products identified under Public Law 115-92, enacted in December 2017, which authorized DoD (now DoW)-FDA collaboration to expedite development and review of products for serious or life-threatening conditions facing American military personnel.
- The FDA issued guidance in 2019 to assist manufacturers developing dried plasma products for transfusion.
- The FDA found that for uses approved under the license, the benefits of Ezplaz transfusion outweigh the risks, and its safety profile is consistent with other plasma products used for transfusion.
- The FDA granted the biologics license to Vascular Solutions, LLC, a subsidiary of Teleflex.
QUOTES:
Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER) says:
“Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable”
“This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”
Anne Eder, M.D, Ph.D., Director of the Office of Blood Research and Review (CBER) says:
“This licensure demonstrates that innovation and rigorous scientific review can advance together, expanding treatment options and novel blood components while maintaining FDA’s standards for safety, purity, and potency”
SOURCE:
For the full breakdown in FDA, click here.