Drugs

FDA Often Wants More Studies for 2-Drug Combos: Blog

While it may seem that fewer Phase 2 and 3 studies would be needed for a fixed-dose drug-drug combination product using two drugs that have already been approved, in fact they often require more studies than single component products, according to a Camargo Pharmaceutical Services 505(b)(2) Blog post. Camargo product ideation consultant Angela Drew writes that of the 93 drug-drug combination products in Camargo’s proprietary 505(b)(2) database for which approval data are available, 63 required at least one Phase 2 or 3 study and 28 required more than four Phase 2/3 studies.

“In many cases,” Drew says, “additional studies beyond those required for the original approvals of the two component drugs are required because FDA must apply what is commonly referred to as the combination rule. This regulations states that ‘two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug.’”

Proving that each component contributes to the safety or efficacy of the product typically requires a multi-factorial study in which each component is compared separately and in combination to a placebo control.

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