FDA Takes Issue With Idelvion Promotional Ads

Biopharmaceutical company CSL Behring’s promotional materials for its hemophilia B drug Idelvion (coagulation factor IX [recombinant], albumin fusion protein) depict a man playing soccer – a sport considered dangerous for patients with hemophilia. The U.S. Food and Drug Administration (FDA) rebuked the company in a public letter for misleading individuals with the bleeding disorder about the drug’s potential to allow treated patients to participate in contact sports.

The agency pointed out that playing certain sports, like soccer, is not recommended for patients with hemophilia “because of the bleeding risk associated with … cuts, scrapes, contusions, and similar injuries.” The letter continued, “A patient being treated through a routine prophylaxis regimen with Idelvion, and whose hemophilia is well-controlled, will nevertheless still have a serious risk for bleeding while engaging in such activities.”

In response, CSL told STAT News, “Our campaign for Idelvion was aimed at empowering patients with hemophilia B to take control of their condition and to encourage them to lead active and healthy lives. However, we acknowledge the FDA’s authority in this matter and have already begun to update our imagery to reflect activities that are lower impact.”

The National Hemophilia Foundation, which receives about $450,000 in annual funding from CSL, also weighed in. “Yes, this is a medium-risk sport… and it’s unrealistic to say that, just because you’re taking this drug, you can play the sport,” said Michelle Rice, senior vice president of external affairs. “And while I agree it would have been misleading to say or for the imagery to say that you can play with no risk, I don’t want to say patients can’t have normal lifestyles. The desire is to lead as normal a life as possible and prophylaxis has allowed us to do that. You know, if your joints and muscles are stronger, you tend to bleed less.”

Source: STAT News, March 7, 2018.