Octapharma Octagam Efficacy Claims Are Unsubstantiated, FDA Warning Letter Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Promotional materials disseminated by Octapharma at an American Academy of Allergy, Asthma & Immunology meeting also failed to reveal risks associated with use of the intravenous immune globulin.
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Claims made by Octapharma in several promotional pieces for the intravenous immune globulin Octagam fail to reveal material facts regarding the risks associated with the product and include unsubstantiated safety and superiority claims, FDA says. FDA's Center for Biologics Evaluation & Research issued the FDL-1 warning letter Aug. 31 after reviewing a file card and dosage guide disseminated at the American Academy of Allergy, Asthma & Immunology meeting in San Antonio, Texas March 18-22. The file card and dosage guide fail to include risk information, even though labeling for Octagam includes a "black box" warning regarding reports of renal dysfunction, acute renal failure, osmotic nephrosis and death associated with the use of IGIV products and another warning regarding products made from human plasma, FDA says. "We note that you do include the statement, 'low adverse events…, ' in the file card, but you provide no additional information on what specific adverse events were observed," the letter states. FDA also cited the company's website, which similarly mentions adverse drug reactions associated with Octagam, but does not mention contraindications, black box warnings or other warnings. FDA also takes issue with unsubstantiated safety claims made by Octapharma, including a statement avowing "unsurpassed viral safety," which could be "interpreted to mean that no other immunoglobulin therapy offers better viral safety than Octagam." Another claim from Octapharma's website says that "over the past 10 years, data from more than 6,100 patients and 90,000 treatment episodes has been gathered" and "no viral transmissions have ever been observed. This proves the excellent safety record of Octagam." FDA says the statement is misleading because the claim is based on a postmarketing study in Europe conducted using a voluntary questionnaire, and therefore does not constitute substantial evidence. FDA also addresses unsubstantiated efficacy claims made on the website, including one that reads, "For patients who undergo bone marrow transplant (BMT), infection with cytomegalovirus (CMV) is one of the major causes of mortality and morbidity. Octagam contains very high titers of CMV antibodies." "These statements are misleading because Octagam was not approved in the U.S. for BMT patients with CMV, and these statements contain favorable conclusions from nonclinical studies of a drug," the letter says. The website also contains inaccurate information regarding the correct storage information for Octagam, CBER's ad division notes. FDA also cites Octapharma for failing to submit promotional materials to FDA at the time of initial dissemination. "You should immediately revise your procedures to ensure submission of all advertising and promotional material to FDA at the initial dissemination," the agency notes. Octagam was approved by FDA in May 2004 (1 (Also see "Octapharma IGIV Octagam Approved" - Pink Sheet, 24 May, 2004.)). -Jessica Merrill |