EU Health Commissioner says plasma donation plays a vital role
June 14, 2021 (Brussels, Belgium) – The Plasma Protein Therapeutics Association (PPTA) is proud to mark World Blood Donor Day. This day is an opportunity to specifically thank plasma donors, as well as blood donors, and recognize their shared commitment and contributions to saving and improving the lives of patients in Europe.
PPTA welcomes EU Health Commissioner Kyriakides’ recognition of the crucial role of plasma and blood donors for people living with chronic and rare diseases, particularly her comment that “Blood plasma also plays a vital role with 8 million litres donated to tackle immune deficiency and make lifesaving medicines for conditions such as haemophilia, a rare condition that affects the blood's ability to clot.” Yet to meet the growing clinical need in Europe, a lot more plasma collection is needed. Europe is today highly dependent on plasma coming from the United States.
Lifting of long-time ban on use of UK plasma for manufacturing of immunoglobulins will help patients
February 25, 2021 (Annapolis, MD) - The Plasma Protein Therapeutics Association (PPTA) welcomes the decision of the UK government to lift a two decades old ban on the use of UK-donated plasma for the manufacture of immunoglobulins, following a scientific review conducted by the Medicines and Healthcare Products Regulatory Agency. The ban was imposed in 1998 to mitigate the spread of variant Creutzfeldt Jakob Disease (vCJD), but experts have now concluded that the use of UK-sourced plasma to manufacture immunoglobulins is safe and can recommence, supported by a set of robust safety measures.
Treatments for rare diseases at risk, due to the decline of plasma donations
Representatives of patient advocacy groups, expert physicians, thought leaders, and representatives from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research came together on December 9 at a roundtable sponsored by the Plasma Protein Therapeutics Association (PPTA) to discuss the impacts on people with rare diseases if not enough plasma is available to manufacture lifesaving plasma-derived therapies. These therapies are often the only treatments available for people with primary immune deficiencies, bleeding disorders, Alpha-1 Antitrypsin deficiency, hereditary angioedema, and certain neurological conditions.
The journal publication, “Immunoglobulin Replacement Therapy is critical and cost-effective in increasing life expectancy and quality of life in patients suffering from Common Variable Immunodeficiency Disorders (CVID): A health-economic assessment,” is authored by Professor Philippe van Wilder with the Université libre de Bruxelles and Professor Esther de Vries of Tilburg University and offers a health economic model to estimate the value of treatment with IG therapy for CVID patients.
New position statement by CHMP regarding donor deferral criteria for sexual behaviour helps assessment of PMFs
The International Plasma and Fractionation Association and the Plasma Protein Therapeutics Association are pleased with the recent publication by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) "CHMP Position statement on quality and safety assessment for the Plasma Master File (PMF) certification with regard to donor deferral criteria for sexual risk behaviour," as such a position was highly needed, especially regarding men-having-sex-with-men (MSM). It clarifies that the application of these nationally defined deferral periods will from now on also be considered when assessing appropriateness of locally collected plasma to be included in a PMF.
Human Plasma Donations Remain Important During COVID-19 Pandemic
In a recent communication, the U.S. Food and Drug Administration (FDA) limits the collection and use of COVID-19 convalescent plasma authorized under Emergency Use Authorization for the treatment of hospitalized patients with COVID-19.1 It is important to note, however, that this development does not mean that the need for plasma donations has diminished. Both normal source plasma donations, from healthy individuals, and convalescent plasma donations, from individuals who have recovered from COVID-19, are still needed to fight COVID-19 and the many non-COVID-19 conditions (e.g., immune deficiencies and blood clotting disorders) for which plasma protein therapies are ordinarily used.
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