Dear GBS|CIDP Community,
We know that this is a challenging time for everyone as the news of the pandemic is evolving each day. Please know we are here for you and the GBS|CIDP Foundation International is committed to addressing your concerns as accurately and efficiently as possible. A number of our members have reached out with regard to safety and availability of CIDP treatments. Therefore, we have connected with our pharmaceutical partners that manufacture and distribute CIDP medicines. Each company quickly responded to our request with an update on how they are managing the COVID-19 situation. We share with you their statements below, and we will continue to provide information that is relevant to our community as it is made available in upcoming days and weeks. You will find all current COVID-19 updates from the Foundation at gbs-cidp.org/covid19
Wishing good health & wellness to all,
Lisa Butler, Executive Director
GBS|CIDP Foundation International
CSL Behring recommends the use of its products only as directed in the approved product labeling. The following information should not be construed as a comprehensive collection of all available clinical/published data regarding this topic.
The company has taken steps to protect patients, to prevent disruption to the supply of our products, and to protect our employees around the world. We have activated our business continuity plan and are closely monitoring and managing as the situation develops.
CSL Behring does source material used in the manufacturing process from areas affected by the coronavirus however, our robust supply lines ensure that these critical supplies are not single source. Therefore, CSL at this time does not expect any negative impact on our ability to supply product globally as a result of the coronavirus epidemic.
The SARS-CoV-2 (viral strain causing COVID-2019) is a large sized virus (approximately 120 nm in diameter). The relatively large size and lipid envelope makes it highly susceptible to steps with virus inactivation and removal capacity used during the manufacturing processes, such as pasteurization, solvent-detergent (S/D), low pH incubation, dry-heat treatment, and virus filtration. The effectiveness of these processes has been demonstrated on other coronavirus lipid-enveloped model viruses which are quite similar to 2019-nCoV, e.g. SARS-CoV, human coronavirus 229E and OC43, and porcine coronavirus TGEV.
Based on these data, we can be assured that existing manufacturing processes will provide significant safety margins for our plasma products against the SARS-CoV-2.
As the situation with the novel coronavirus rapidly evolves, we wanted to inform you that Grifols is taking measures in line with recommendations from the World Health Organization (WHO) to help ensure the safety of our employees, donors, products, and the patient communities we serve. We have also made our expertise in plasma available to health authorities since the outbreak began.
Aware that our products and services are important to patients and healthcare providers around the world, we can confirm at this moment there are currently no supply delays or interruptions as a result of the novel coronavirus.
Every single donation at Grifols goes through exhaustive analyses to ensure it meets our strict requirements. However, out of an abundance of caution, we are implementing additional protocols in our donor centers to ensure donor eligibility. Furthermore, our plasma product manufacturing process contains dedicated steps for viral inactivation that ensure high safety margins against this type of virus.
Grifols has deep expertise and technology in the use of virally inactivated convalescent plasma – plasma obtained from recovering patients – to develop potential anti-viral immunoglobulin treatments. This expertise has already been shared with our partner-to-be in China, Shanghai and the Chinese public health system. We are also making it available to other international public health authorities. At the same time, Grifols is accelerating the development of screening and testing methods for the detection of the novel coronavirus.
Grifols is closely monitoring developments. We will continue to take actions, in consultation with advice from the WHO and associated government agencies, to protect our employees, ensure our medicines and products reach those who need them, and do what we can to help combat the coronavirus.
For additional information, please see the statement from the Plasma Protein Therapeutics Association (PPTA).
April 6, 2020
Dear GAMMAKED™ Customers,
With a commercial presence in over 100 countries, we here at Kedrion Biopharma are closely monitoring the COVID-19 pandemic. In the US alone, we have over 900 employees. We remain committed to acting in the best interest of our employees, business partners, healthcare professionals, and patients we serve during this time. As such, I am writing to address a concern you may have regarding the safety and supply of GAMMAKED™ [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] in this current and unprecedented environment.
Kedrion Biopharma is a member of the Plasma Protein Therapeutics Association (PPTA). As such, Kedrion Biopharma adheres to strict manufacturing processes according to the highest standards of quality – including Quality Standards of Excellence, Assurance and Leadership (QSEAL) set forth by the PPTA. In accordance with PPTA protocols, regular donor screening and testing procedures are in place to prevent any individual from donating plasma who shows signs of illness.1
Due to the nature of the SARS-CoV-2 virus and the strict manufacturing protocols required for its members, the PPTA considers that COVID-19 is not a concern for the safety of plasma protein therapies manufactured by PPTA member companies.2
The safety of our products and patients is of highest priority. As you know, GAMMAKED™ is an immune globulin injection that is approved to treat primary humoral immunodeficiency (PI) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.3
We are confident in assuring you that your GAMMAKED™ supply will not be affected by the ongoing COVID-19 pandemic. The supply agreement with our 3rd party manufacturer is currently active and remains intact through 2023. With a relatively small percentage of our business in the acute care hospital setting, our supply is not impacted by the increasing demand for IGIV within this setting.
We want to assure you that we remain committed to our patients and currently have a sufficient supply of GAMMAKED™ to meet patient needs in 2020 and beyond. In addition, our plasma collection has not been interrupted at this time so the future supply of product should remain strong. We remain committed to providing GAMMAKED™ to all of our current patients. By choice, we are not taking on new patients at this time in order to dedicate 100% of our supply to patients currently on the product. We have been, and remain, steadfast in this decision. Please know that patients who choose to remain on GAMMAKED™ will continue to receive quality support from Kedrion Biopharma, Inc. in order to remain on the product.
Kedrion Biopharma’s patient-centric vision remains at the center of everything we do. Our hearts are with you during these uncertain times and we are committed to doing all we can to help you remain healthy and safe in this challenging environment.
Vice President, Commercial Head North America
References:1. Kedrion Biopharma. Kedrion.us. https://www.kedrion.us/plasma-25. Updated December 2019. Accessed April 1, 2020. 2. PPTA. Pptaglobal.org. https://www.pptaglobal.org/media-and-information/ppta-statements/1055-2019-novel-coronavirus-2019-ncov-and-plasma-protein-therapies. Updated March 13, 2020. Accessed April 1, 2020. 3. GAMMAKED™ [prescribing information] Fort Lee, NJ. Kedrion Biopharma Inc. 2018.
GAMMAKED™ is a registered trademark of Kedrion Biopharma Inc.
All other trademarks are the property of their respective owners.
©2020 Kedrion Biopharma Inc. All Rights Reserved. March 2020 KT-000-00-2020B
Statement concerning the impact of SARS-CoV-2 on supply for patients receiving
Takeda plasma derived therapies. Takeda does not anticipate any impact to plasma collection and third-party plasma sourcing at this time. We continue to monitor the situation and, so far, have seen no drop-off in plasma donation. Our collection centers are predominantly in the US, as well as in Czechia, Hungary and Austria. Nor do we anticipate any impact to continuity of planned supply of our plasma-derived therapies. We continue to monitor the situation and have formed critical event response teams who are working on contingency planning across our business, including collection, laboratory, manufacturing and delivery.
Regarding safety, in view of the strict screening procedures in place for plasma donors and the established processes for viral inactivation and removal during manufacturing of plasma-derived therapies, Takeda does not expect that the SARS-CoV-2 is a concern for the safety margins of our plasma-derived therapies. The industry view from the Plasma Protein Therapeutics Association and additional background information is available via their website.
As a precaution, we have made arrangements for notices to be posted in all our plasma collection centers worldwide and for questions on potential exposure risk to be included in the medical examination. In addition, we have provided guidance to our centers on the steps to be taken in the event that there is deemed to be a risk. This guidance aligns with all national requirements. Additionally, this week Takeda announced that we are initiating the development of a plasma-derived therapy for COVID-19 which we are calling TAK888. The anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) is being developed to treat high-risk individuals with COVID-19. SARS-CoV-2 is the virus that causes COVID-19.
Both plasma sourcing for, and production of, TAK888 will be separate from our existing plasma collection and manufacturing given the unique nature and intended therapeutic use of this therapy; therefore, we do not anticipate directly affecting planned supply of our existing immune globulins.