Drugs

BMJ Study Questions Post-approval Study Data Quality/Quantity

Data from post-approval clinical trials required for certain novel drugs approved on limited evidence (e.g., surrogate endpoints) varied in quality and quantity, “with few controlled studies published after approval that confirmed efficacy using clinical outcomes for the original FDA approved indication,” according to a new study in the British Medical Journal.

The study looked at 117 novel drugs for 123 indications approved between 2005 and 2012 on the basis of a single pivotal trial. “Overall, no postapproval studies were identified for 43 of the 123 (35.0%) approved indications,” study authors said. Less than one-tenth of new drug indications approved by FDA on the basis of surrogate markers of disease “had at least one post-approval trial validating the use of the surrogate marker by showing superior efficacy using clinical outcomes,” they added.

“To strengthen lifecycle evaluation of recently approved drugs, requirements for postapproval studies should be heightened and may need to specify study design characteristics or trial endpoints in detail to ensure that these studies provide high quality evidence to further inform clinical practice,” the study authors concluded. “Of course, it must be remembered that publishing one short term, small post-approval study might be inadequate for a hypertension drug but entirely reasonable for one treating a rare disease. A customized, specific plan for post-approval studies will be key to generating an adequate amount of postapproval evidence on comparative efficacy, which should take into consideration disease prevalence and severity, the drug’s anticipated length of use, and the availability of other treatment options.”

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