Drugs

FDA Hits Tremfya TV Ad as ‘False or Misleading’

The CDER Office of Prescription Drug Promotion (OPDP) says a Janssen Biotech direct-to-consumer TV ad for its ulcerative colitis drug Tremfya (guselkumab) injection, for subcutaneous or intravenous use, is false or misleading. A 2/6 Notice of Violation takes issue with the ad’s claims that about one out of two patients experienced remission at one and even two years.

OPDP says that in two follow-up trials, some 38% or 39% of patients did not respond to treatment at week 12. The letter also faults the ad for suggesting that findings at one year and two years were in the same population when, in fact, they were different subsets.

The letter says the ad’s claims about healing the intestinal lining misleadingly overstate the drug’s effectiveness. Further, it says, the ad has claims and presentations about the uses and benefits of Tremfya, but omits material risk information pertaining to the Warning and Precautions for infections.

Janssen was told to respond with a list of all promotional communications for Tremfya with representations like those described in the letter and a plan to either discontinue the communications or stop distributing the drug.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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