Drugs

FDA Hits Sobi’s Vonjo TV Ad as Misleading

FDA has issued Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (pacritinib) because it misbrands the product and violates federal law by making misleading benefit claims and omitting key safety information. The just-posted 2/6 letter from CDER Office of Prescription Drug Promotion (OPDP) says the TV ad falsely suggests the drug improves patients’ quality of life, overstates its approved indication, and downplays serious risks associated with treatment.

The ad, submitted under Form FDA 2253, repeatedly urges patients to “turn the page with VONJO,” accompanied by imagery of an older man walking his dog, socializing, eating ice cream in a park, and dancing. According to FDA, the combination of claims and visuals implies that Vonjo improves emotional and social functioning, even though the drug failed to demonstrate such benefits in a key clinical endpoint.

FDA notes that one of the two coprimary endpoints in the Phase 3 PERSIST-2 trial — a reduction in Total Symptom Score measuring patient-reported symptoms of myelofibrosis — did not meet statistical significance compared with best available therapy.

“The totality of these claims and presentations makes the TV ad misleading,” the agency writes.

FDA also faults the ad for inadequately describing Vonjo’s approved indication. While the ad refers broadly to patients with “low” platelet counts, it does not specify what is considered “low,” according to the letter.

In addition, FDA says the ad fails to adequately communicate serious safety risks. The agency cites the omission of information about severe bleeding, potentially life-threatening cardiac rhythm changes, severe diarrhea, and an increased risk of major cardiovascular events such as heart attack, stroke, or death, particularly in patients with cardiovascular risk factors.

FDA further criticizes the ad’s presentation of risk information, saying fast-paced visuals, scene changes, background music, and a “pop-up book” theme distract viewers during the major statement, interfering with comprehension of the drug’s risks.

The agency letter requests that Sobi immediately cease the misleading promotional communications and submit a written response within 15 working days outlining corrective actions, identifying similar promotional materials, and explaining plans to discontinue or revise them.

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

Read more

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