Octapharma USA Receives FDA Emergency Use Authorization for octaplasLG Powder, Allows U.S. Military Medical Providers Emergent Use in Treatment of Hemorrhage or Coagulopathy

PARAMUS, N.J., Aug. 20, 2024 /PRNewswire/ -- Octapharma USA has received U.S. Food and Drug Administration Emergency Use Authorization (EUA) for its proprietary octaplasLG Powder (blood group types A and AB). The EUA allows U.S. Department of Defense medical providers to administer the powder as a lifesaving measure during treatment of hemorrhage or coagulopathy in military emergencies when fresh frozen plasma (FFP) is not available or when the use of plasma is not practical.¹

The EUA permits U.S. military medical providers and other trained U.S. military personnel to administer octaplasLG Powder to uniformed U.S. military members, civilians, contractors, and allied military personnel during military operations when alternative treatments are unavailable and within the guidelines of the EUA.

OctaplasLG Powder is an unapproved lyophilized form of Octapharma's FDA-approved octaplas^®, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion. The safety and efficacy of octaplas^®, approved by the FDA in 2013, has been demonstrated through substantial post-marketing research since it entered the global market in 1992.²

OctaplasLG Powder, which is commercially available in 27 countries internationally, is for use under emergency conditions when plasma is not available or when the use of plasma is not practical. OctaplasLG Powder does not require refrigeration and is supplied in a form compatible with the logistical constraints of military emergencies. The octaplasLG Powder EUA is limited to products of blood groups A and AB, which can be transfused to recipients of any blood group when their blood group cannot be determined in an emergency.³ Octapharma will provide DoD with an infusion set to be utilized with the product.

In April 2024, Octapharma USA entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Materiel Development Activity's (USAMMDA) Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO). The CRADA outlines roles and responsibilities for collaborative research and development and EUA submission on the freeze-dried plasma product (octaplasLG Powder) between Octapharma USA and the Department of Defense (DoD). USAMMDA is a subordinate unit of the U.S. Army Medical Research and Development Command.

"USAMMDA welcomes the FDA's decision to issue the EUA as it will provide medics with additional options and greater flexibility when treating hemorrhage at the point-of-injury in far-forward and austere environments," stated Colonel James (Andy) Nuce, Commander of USAMMDA.

Octapharma's Commitment to Critical Care
"Octapharma is committed to providing the U.S. military with a safe alternative to fresh frozen plasma when life-threatening hemorrhage or coagulopathy needs to be addressed during emergencies," said Octapharma USA President Flemming Nielsen. "For many years, Octapharma has recognized the challenges of managing excessive bleeding and blood clotting challenges in emergency situations. Over the last two decades, Octapharma has funded extensive research and development of octaplasLG Powder to demonstrate our vision to provide patients worldwide the critical care therapies they need to overcome life-threatening challenges."

Controlled clinical studies of octaplasLG Powder have not been performed. Information on safety and efficacy of octaplasLG Powder is derived from information on the safety and efficacy of octaplas^®, along with laboratory studies suggesting similar composition and quality of octaplasLG powder when reconstituted to octaplas^®.⁴ DoD personnel will collect data under the EUA to evaluate the appropriate and safe use of octaplasLG Powder under emergency conditions, including suspected adverse reactions and medication errors.⁵

OctaplasLG Powder is made entirely from plasma obtained from U.S. licensed blood centers. All plasma donations are tested for relevant transfusion-transmitted infections in accordance with U.S. federal regulations. The plasma also undergoes a solvent/detergent treatment manufacturing process to inactivate infectious agents further helping to ensure its safety. Octaplas^® is then freeze-dried to create octaplasLG Powder.

About the FDA Emergency Use Authorization
The EUA is a tool used by the FDA to expedite the availability of medical products, including vaccines and drugs, during a public health emergency. The FDA will only grant an EUA when no approved and available alternatives exist, and when the known and potential benefits outweigh the potential risks. The EUA program was created in 2004 to respond to the danger of bioterrorist attacks, including anthrax. The EUA program has been used to address many public health threats, including COVID-19, H1N1 (swine flu), Ebola, avian flu, and Middle Eastern Respiratory Syndrome (MERS). The FDA can update or cancel any EUA, including the octaplasLG Powder approval, as the agency assesses current needs and available data.

OctaplasLG Powder is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of octaplasLG Powder for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Octaplas^®
Octaplas^®, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion is a solvent/detergent (S/D) treated, pooled human plasma indicated for:

• Replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease; or undergoing cardiac surgery or liver transplantation
• Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)

Contraindications

• IgA deficiency
• Severe deficiency of Protein S
• History of hypersensitivity to fresh frozen plasma (FFP) or to plasma derived products including any plasma protein
• History of hypersensitivity reaction to Octaplas^®

Warnings and Precautions

• Transfusion reactions can occur with ABO blood group mismatch
• High infusion rates can induce hypervolemia with consequent pulmonary edema or heart failure
• Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha 2-antiplasmin
• Thrombosis can occur due to low levels of Protein S
• Citrate toxicity can occur with volumes exceeding one milliliter of Octaplas^® per kg per minute
• Octaplas^® is made from human blood and may carry the risk of transmitting infectious agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease and Creutzfeldt-Jakob disease agent

Adverse Reactions
The most common adverse reactions observed in ≥ 1% of patients included pruritis, urticaria, nausea, headache, paresthesia. Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and hypotension.

Please see Octaplas^® full Prescribing Information. For more information about Octaplas^®, please visit octaplasusa.com.

About USAMMDA
The U.S. Army Medical Materiel Development Activity (USAMMDA), part of the U.S. Army Medical Research and Development Command, develops, delivers, and fields critical drugs, vaccines, biologics, devices, and medical support equipment to protect and preserve the lives of Warfighters across the globe. USAMMDA project managers guide the development of medical products for the U.S. Army Medical Department, other U.S. Services, the Joint Staff, the Defense Health Agency, and the U.S. Special Forces community. The process takes promising technology from DoD, industry, and academia to U.S. Forces, from the testing required for U.S. Food and Drug Administration approval or licensing to fielding and sustainment of the finished product.

The information contained in this press release does not necessarily reflect the position or the policy of the U.S. Department of Defense, USAMRDC, or USAMMDA, and no official endorsement is made or inferred.

About Octapharma
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs nearly 12,000 employees worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. Octapharma has over 40 years of experience in patient care. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com.

REFERENCES
1 – octaplasLG Powder U.S. Food & Drug Administration Emergency Use Authorization (PDF), August 8, 2024.

2 - octaplas^® Prescribing Information.

3 - octaplasLG Powder Fact Sheet for Recipients (PDF).

4 - Data on File, Octapharma USA, August 2024.

5 - octaplasLG Powder Fact Sheet for Health Care Professionals or Other Authorized Providers (PDF).

OPLAS-0168

SOURCE Octapharma