Drugs

FDA Denies Petition Seeking Savella Withdrawal

FDA has denied a Public Citizen petition that urged the agency to remove from the market Cypress Bioscience/Forest Laboratories’ Savella (milnacipran). The 1/20/2010 citizen petition said the drug, approved 1/14/09 for managing fibromyalgia in adults, has highly questionable clinical efficacy and has been found in controlled trials to cause a large number of potentially serious adverse reactions including hypertension, increased heart rate, and increased suicidal ideation.

According to Public Citizen, basing Savella’s approval on analysis of two clinical trials “was a twisted path.” It said that when the first trial failed to achieve statistically significant results, the sponsors performed a post-hoc reanalysis of the data and used those more favorable results to plan the second trial. Changes necessary to obtain significant results in the second trial, the petition said, included replacing a function endpoint, increasing the number of patients in the trial, excluding patients with moderate to severe depression, increasing the size of the trial, limiting the trial’s duration to three months, and changing the method for handling missing data. Statistically significant results also required employing composite rather than single endpoints, it added.

In denying the petition, FDA said it disagrees with the group’s contention that Savella should not have been approved. It said the clinical data showed that more patients in the Savella treatment arms experienced at least a 30% reduction in pain from baseline than patients in the placebo arm.

Addressing the petition’s concern about the endpoints used, the denial letter said that while there was “little difference” between Savella and placebo when each endpoint was looked at individually, the drug shows a statistically significant effect in patients who achieved a reduction in all three endpoints of pain, function, and patient global assessment. “FDA concluded that these results were sufficient to demonstrate that Savella improves the symptoms of fibromyalgia,” the letter said.

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