Drugs

Cytokinetics Suspends ALS Drug Program After Phase 3 Data

Cytokinetics has suspended its tirasemtiv drug development program after receiving disappointing data from the VITALITY-ALS Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS). The company says the study did not meet the primary endpoint of change from baseline in “slow vital capacity” (SVC) that was evaluated at 24 weeks following randomization or any of the secondary endpoints. It says no new safety or tolerability findings were identified in the study.

“The decline in SVC from baseline to 24 weeks was smaller in patients who received any dose of tirasemtiv in VITALITY-ALS compared to the decline in patients receiving placebo,” Cytokinetics says. The largest differences, while not statistically significant, were observed in patients randomized to the mid- and high-dose groups who could tolerate and remain on their target dose, it explains.

Cytokinetics is hopeful that its next-generation fast skeletal muscle activator, CK-2127107, will see more promising results. “Based on previous Phase 1 clinical studies, we believe CK-2127107 will be better tolerated and potentially more effective than tirasemtiv in patients with ALS and look forward to Phase 2 trial results in 2018,” it says. “CK-2127107 was derived from a different chemical structural class and was designed to have certain advantages relative to tirasemtiv. CK-2127107 appears to be more potent than tirasemtiv in preclinical models and in humans and appears better tolerated compared to tirasemtiv. CK-2127107 has demonstrated pharmacological activity that may lead to new therapeutic options for diseases associated with muscle weakness and fatigue.”

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