Drugs

Novartis’ Mayzent Approved for Multiple Sclerosis

FDA has approved a Novartis NDA for Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Approval is based on data from a 1,651-patient clinical trial that compared Mayzent to placebo in patients with secondary progressive multiple sclerosis (SPMS) who had evidence of disability progression in the prior two years and no relapses in the three months prior to enrollment, according to an agency release. The primary endpoint was the time to three-month confirmed progression in disability.

“The fraction of patients with confirmed progression of disability was statistically significantly lower in the Mayzent group than in the placebo group,” FDA says. “Mayzent also decreased the number of relapses experienced by these patients. In the subgroup of patients with non-active SPMS, the results were not statistically significant.”

FDA’s approval also requires Mayzent to be dispensed with a patient Medication Guide that describes important information about its uses and risks. “Mayzent may increase the risk of infections, so patients should have a complete blood count taken before treatment is initiated,” FDA says. “The drug may cause macular edema, so patients should contact their physician if they experience a change in vision. Mayzent may cause transient decreases in heart rate and may cause a decline in lung function. Liver enzymes should be checked before initiation of the drug and health care professionals should closely monitor patients with severe liver impairment. Health care professionals should monitor the patient’s blood pressure during treatment.”

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