Drugs

Database Studies Can Support sNDAs: Study

Harvard Medical School researchers say that in some situations, database studies may support supplemental applications for effectiveness for already approved drugs. Writing in JAMA Internal Medicine, the researchers describe their use of healthcare databases to replicate the study of Boehringer Ingelheim’s antihypertensive Micardis (telmisartan) for a supplemental indication to reduce cardiovascular risk. Study patients had been given either Micardis or Pfizer’s Altace (ramipril), or a combination of the two.

“Among patients newly prescribed telmisartan and ramipril before FDA’s decision to approve a supplemental indication for telmisartan,” the article says, “we found results that were almost identical to those of the randomized clinical trial that led to telmisartan’s supplementary indication.”

The researchers say their study is one of the largest to analyze real-world data to mirror a large randomized clinical trial that had established the clinical basis for a supplemental indication for a medication.

“FDA is currently considering how it will use nonrandomized, real-world data as part of a supplemental indication application,” the authors conclude…. “Many context-specific questions about study design, confounding control, data quality, and outcome validity will need to be considered…. Regulators have a difficult task in providing specific rules for decision making in this maturing yet still developing and highly context-specific field. However, if done selectively and with principled methods, it might be feasible to use nonrandomized, real-world data to provide supportive evidence in establishing supplemental drug indications.”

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