Drugs

FDA Rescinds Teva SPA After Dosing Changed

FDA has told Teva Pharmaceutical Industries that a previously agreed to Special Protocol Assessment (SPA) has been rescinded for the Phase 3 CONCERTO clinical trial evaluating laquinimod in relapsing remitting multiple sclerosis (MS). Earlier this year, Teva and its development partner Active Biotech confirmed that the highest dose arms in two MS trials and one trial in Huntington’s Disease were discontinued at the recommendation of a data monitoring committees. Subsequently, Teva submitted an amendment to the SPA to account for this change. However, under FDA’s regulatory process, the SPA was rescinded as all changes must be agreed to prior to implementation of the change. “This requirement could not be fulfilled in the current case, since the DMC recommendation triggered an immediate action to withdraw the 1.2 mg dose for the treatment of RRMS in the interest of patient safety” Active Biotech says.

The CONCERTO trial continues with one dose (0.6mg/day) vs. placebo on the original schedule, and Teva plans to use this pivotal study to support filing for marketing approval for laquinimod in the U.S. and EU. Teva has completed two Phase 3 trials with the 0.6mg daily dose in MS and continues long-term extension studies at this dose.

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