Drugs

2 Voucher Program Drug Reviews Delayed: Reuters

FDA has delayed its review of Sanofi’s diabetes drug Tzield (teplizumab-mzwv) and Disc Medicine’s blood disorder medication bitopertin due to safety and efficacy concerns. An exclusive Reuters story says both drugs were being reviewed as part of the new Commissioner’s National Priority Voucher Program, which promised decisions in one to two months for a limited number of drugs that met specified criteria involving public health, national security, domestic manufacturing, or price.

According to Reuters, reviewers cited Tzield adverse event reports, including two related to seizure and blood clotting, and one death. Concerns raised about bitopertin reportedly included trial data and the risk of abuse.

The delays had not been previously reported, Reuters says, and the two companies declined to comment to the news service.

HHS spokesman Andrew Nixon told Reuters that FDA does not comment on applications that are under review and that review divisions are granted flexibility to adjust timelines.

Reuters further reports that reviews of Lilly and Boehringer Ingelheim drugs in the voucher program are taking longer than planned.

Drug review experts contacted by the news service said the delays are reassuring since the promised one- to two-month review time led to questions about how rigorous the reviews would be.

“It is a very good sign [that] FDA in this program is willing to say, ‘Hold on, we’re not actually sure this product should be allowed on the market,’” said University of Pennsylvania health policy professor Holly Lynch. The report says Lynch and others said they still have concerns about the voucher program politicizing drug reviews since the Trump administration is selecting the drugs to be included, and final approval rests with a panel of senior FDA officials rather than staff reviewers.

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