Drugs

Draft Guide on Pulmonary Tuberculosis Drugs

FDA has released a draft guidance entitled “Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.” The document is intended to provide current agency recommendations regarding the overall development program for a new investigational drug or drugs to be used in combination with approved drugs, or as a new treatment regimen that includes one or more investigational drugs to support an indication for the treatment of pulmonary TB. FDA notes that the guidance does not address the development of drugs for latent TB infection or for extrapulmonary TB.

As a general consideration, the guidance says antimycobacterial drug activity can be evaluated in trials of early bactericidal activity (EBA) or in Phase 2 trials that evaluate microbiological outcomes at early time points. “For a combination regimen, the sponsor should evaluate the contribution of each drug to the treatment effect,” it says. It also recommends that sponsors consult with the agency early in development on their plans to demonstrate the contribution of the investigational drug as part of a combination regimen.

Additionally, FDA says, if applicable to the study drug, “EBA trials evaluating the quantitative counts of viable M. tuberculosis from daily collections of sputum can provide information on the bactericidal activity of antimycobacterial drugs.” Such trials are intended to evaluate antimycobacterial activity of drugs alone or in combination over a brief time course (seven to 14 days). “EBA trials can provide preliminary evidence for the contribution of each drug to the treatment effect of the combination regimen,” it says.

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