Drugs

Glenmark NDA Accepted for Allergy Nasal Spray

FDA has accepted for review a Glenmark Pharmaceuticals NDA for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), an investigational fixed-dose combination antihistamine/steroid nasal spray for treating seasonal allergic rhinitis in patients 12 years of age and older. The submission includes efficacy and safety results from two pivotal, placebo-controlled trials in 2,352 adults and adolescents 12 years of age and older. “Assessment of efficacy was based on patient-reported reflective total nasal symptom score (rTNSS), along with other patient-reported measures of nasal and ocular symptoms,” the company says. Data from these showed that treatment with Ryaltris resulted in statistically significant improvements in rTNSS compared to placebo, it says.

Additionally, the NDA includes data from a long-term safety study in 601 adults and adolescents who were randomized to 52 weeks of twice-daily treatment with Ryaltris, or two different formulations of a placebo nasal spray. “The incidence of adverse reactions in four placebo-controlled clinical studies was 13.9% in the Ryaltris treatment groups versus 9.5% of patients in the placebo groups,” Glenmark says. “The most frequently reported adverse reactions with Ryaltris greater than placebo was loss of taste sensitivity (3.0% vs. 0.3%, respectively), nosebleed (1.0% vs. 0.6%) and nasal discomfort (1.0% vs. 0.8%).”

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