News 12 New Jersey, 5.21.20
In this interview, Octapharma USA SVP Commercial Development, Rich Walters, speaks about the rapid FDA approval Octapharma USA received to conduct a phase 3 clinical trial on the use of IVIg to treat seriously ill COVID-19 patients and the plans for immediate study deployment.
Octapharma is studying whether “off the shelf”, currently available IVIg can help COVID-19 patients, as well as working with other companies to manufacture coronavirus-specific immunoglobulin derived from convalescent plasma collected from people who have recovered from the disease.
Wall Street Journal, 5.3.20
Researchers are investigating whether a common blood-plasma product used in treating immune-system disorders could also be effective in coronavirus patients and potentially shape future trials of new treatments specific to COVID-19. If proved effective, standard IVIg could offer an immediate new treatment option, because it is already in stock in many hospitals.
Octapharma USA, 12.2.20
Clinical research presented by Octapharma USA at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition highlighted the investigational use of high-dose Octagam® 10% [Immune Globulin Intravenous (Human)] for the most severe COVID-19 patients. The study evaluated the standard of care (SOC) plus high-dose Octagam® 10% compared to SOC alone in the treatment of COVID-19 infection. Findings suggest that use of intravenous immunoglobulin therapy may reduce progression to mechanical ventilation in COVID-19 patients with moderate to severe hypoxia.
Octapharma USA, 9.8.20
In a small-sample, investigator-led California study supported by Octapharma, Octagam 10% [Immune Globulin Intravenous (Human)] was used with COVID-19 patients experiencing hypoxia and at risk of requiring mechanical ventilation. After treatment with intravenous immunoglobulin (IVIg) patients in the study saw significantly improved hypoxia, reduced length of hospital stay, and reduced progression to mechanical ventilation.1 While the results of the small sample size are not statistically significant, they point to a potential benefit of IVIg in treatment of COVID-19, as well as to the importance of optimal patient selection for IVIg in maximizing clinical benefit.
Octapharma USA, 5.27.20
Octapharma USA and BioMatrix Specialty Pharmacy are supporting a new investigator-initiated research study led by Kelly McCants, M.D., Medical Director of the Norton Heart & Vascular Institute in Louisville, Ky., focused on treating patients with the COVID-19 and presenting with COVID-19-associated myocardial dysfunction.
Octapharma USA, 5.20.20
The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application submitted by Octapharma USA for a phase 3 clinical trial on the efficacy and safety of IVIg treatment in COVID-19 patients with severe disease progression. A multi-center U.S. clinical trial will begin immediately to evaluate if high-dose intravenous immunoglobulin (IVIg) can stabilize or improve patient clinical status.
Octapharma USA, 4.16.20
Octapharma USA is supporting a new investigator-initiated clinical trial led by George Sakoulas, M.D. of Sharp Memorial Hospital in San Diego, California, focused on treating the most critical patients at the heart of the coronavirus pandemic, those experiencing respiratory failure who become ventilator dependent. The trial is entitled Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIg) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection and will study whether IVIg can halt coronavirus progression to respiratory failure, reduce days requiring oxygen, and reduce length of hospital stay.
Octapharma is putting its expertise to work to find new treatments for COVID-19 as part of its ongoing commitment to its patients. The company has launched a special project team to explore new therapies, and today announced that in addition it has also joined other global leaders in plasma fractionation in a collaboration to develop a potential plasma-derived hyperimmune immunoglobulin therapy for treating COVID-19.
A message from Wolfgang Marguerre, Chariman and CEO, Octapharma Group, assures patients that the company is doing everything it can to ensure they continue to receive the medicines they need to stay healthy, detailing the various corporate initiatives that have been implemented.
Octapharma USA, 2.6.20
With global health concerns regarding the 2019 novel Coronavirus (SARS-CoV-2) continuing to rise, hospital administrators and healthcare professionals are evaluating their options for providing patients with blood products that have an added level of safety. “Octaplas™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, provides that peace of mind the healthcare community is looking for,” said Octapharma USA President Flemming Nielsen.