Drugs

Idelvion Promotions Misleading: CBER

The CBER Advertising and Promotional Labeling Branch (APLB) says that a Web site, patient brochure, exhibit panel, and sales aid for CSL Behring’s Idelvion (coagulation Factor IX [recombinant] albumin fusion protein) make misleading claims about the product’s effectiveness, causing the drug to be misbranded. A 2/27 Notice of Violation says Idelvion is indicated for use in children and adults with hemophilia B (congenital Factor IX deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce frequency of bleeding episodes. It is not indicated for immune tolerance induction in patients with hemophilia B.

There are several Warnings and Precautions in the drug’s labeling.

APLB says the promotional materials all contain claims and presentations that misleadingly overpromise the effect that the drug will have on a hemophilic patient’s activities and overall quality of life. “Overall,” the letter says, “your claims and presentations misleadingly imply that hemophiliacs taking Idelvion can engage in moderate to dangerous high-risk activity without consequences and that such activities are appropriate for typical patients with hemophilia using the product.”

The agency tells Behring to stop disseminating the cited promotional materials as well as any other materials with the same or similar claims or presentations. The company was told to submit a list of violative materials and its plan for discontinuing use of such materials.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome