Drugs

Nicox Plans NDA for Glaucoma Drug

Nicox says it will submit an NDA early next year after new data from its DENALI Phase 3 study of glaucoma therapy NCX 470 showed promising results. The study, which enrolled 696 patients with open-angle glaucoma or ocular hypertension across 90 sites in the U.S. and China, showed that once-daily NCX 470 0.1% eye drops were non-inferior to the widely used standard of care, latanoprost 0.005%, in lowering intraocular pressure. Patients treated with NCX 470 saw reductions of 7.9 to 10.0 mmHg from baseline, compared with 7.1 to 9.8 mmHg for latanoprost, the company says.

In a pre-specified secondary analysis, NCX 470 demonstrated statistically significant superiority over latanoprost at three of six timepoints and numerical improvements at five of six, though the trial did not meet its overall superiority benchmark, Nico says.

It says safety results were consistent with previous studies, with the most common side effect being conjunctival hyperemia (eye redness), reported in 22% of NCX 470 patients compared with 9.2% of those on latanoprost. No serious treatment-related ocular or systemic adverse events were observed, according to the company.

Nicox said it plans to meet with FDA in advance of its NDA filing and will present additional DENALI data at upcoming ophthalmology meetings.

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