Drugs

Acorda Phase 3 Parkinson’s Study Sees 5 Deaths

A Phase 3 study by Acorda Therapeutics of tozadenant for Parkinson’s disease could be in jeopardy after the company reports five deaths in the study and recommending increased frequency (weekly) of blood cell count monitoring for trial participants. The increased monitoring is in response to cases of agranulocytosis, possibly drug-related, and in some cases associated with sepsis and death, Acorda says. Agranulocytosis is the absence of white blood cells, which fight infection. The company has also stopped new enrollment in long-term safety studies, pending further talks with FDA and its data safety monitoring board.

The Phase 3 program includes an ongoing pivotal efficacy and safety study (CL05) and two long-term safety studies (CL05 extension and CL06). To date, about 890 patients have been exposed to tozadenant and 234 have been exposed to placebo, Acorda says. “There have been seven cases of sepsis, all in the tozadenant groups, five of which were fatal,” it says. “Four of the sepsis cases were associated with agranulocytosis, two had no white blood cell counts available at the time of the event and one had a high white blood cell count.

Tozadenant is an oral adenosine A2a receptor antagonist currently in Phase 3 development as an adjunctive treatment to levodopa in Parkinson’s disease patients to reduce “OFF time.” A2a receptor antagonists have the potential to be the first new class of drug approved in the U.S. for improving motor symptoms in Parkinson’s disease in over 20 years, Acorda 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