Drugs

Roche Advancing Parkinson’s Drug Into Phase 3

Roche says it is moving its Parkinson’s drug prasinezumab into a Phase 3 trial after two mid‑stage trials and their open‑label extensions hinted at a disease‑slowing effect in early‑stage disease. Prasinezumab, a monoclonal antibody, is designed to target aggregated alpha-synuclein. A 2022 Phase 2 study failed when its primary outcome did not differ significantly between either the active-treatment group or placebo.

The decision to advance the drug’s development also comes despite it being revealed last year that the drug’s research was called into question because of falsified research publication allegations involving one of NIH’s then-top officials, neuroscientist Eliezer Masliah. The journal Science said Masliah’s work helped gain a research nod from FDA for clinical trials of prasinezumab, which is intended to attack alpha-synuclein, whose build-up in the brain has been linked to the condition’s debilitating physical and cognitive symptoms.

An investigation by Science raised issues with research conducted and published over the past two decades by Masliah. As Science was unveiling its findings from a two-year probe, NIH simultaneously released a statement saying that following its investigation, it ha d “made findings of research misconduct” against Masliah for “falsification and/or fabrication involving re-use and relabel of figure panels” in two publications.

In announcing the decision to advance the drug, Roche says the “totality of data suggest that prasinezumab may have the potential to become the first disease‑modifying treatment for people with Parkinson’s disease.” The company says trial data show that time to confirmed motor progression improved for patients taking prasinezumab, but it was not statistically significant. Regarding the drug’s durability, the company says two‑year follow‑up data suggest a 30‑40 % relative reduction in motor progression versus placebo, an effect that appears to persist in ongoing open‑label extensions involving more than 750 participants.

Jefferies analysts put the probability of Phase 3 success at just 25‑40 %, noting the antibody acts outside neurons and questioning whether that is sufficient to halt intracellular α‑synuclein spread, according to biospace.com.

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