Drugs

FDA Denies Petition Seeking Valtoco NDA Rejection

FDA has denied an 11/1/19 petition filed by Arent Fox asking that the agency deny approval of an NDA for Neurelis’ Valtoco (diazepam nasal spray) until additional clinical studies are conducted. The agency approved the NDA 1/10 contemporaneously with the petition denial.

The petition had asked that FDA:

require Neurelis to conduct a bridging study comparing Valtoco to Diastat in patients, demonstrating comparable exposure to support approval of the NDA;
require Neurelis to conduct a food effect study for Valtoco that would allow for adequate labeling to address the curiously-delayed Tmax that suggests the product is primarily swallowed and absorbed through the GI tract and not nasally; and
should determine that Valtoco is not clinically superior to nor offers a major contribution to patient care when compared to Diastat.

A supplemental petition received by FDA 12/4/19 said that the agency:

should require Neurelis to reformulate Valtoco to remove vitamin E or conduct a study to determine whether the vitamin E-containing nanoparticles in Valtoco’s nasal spray are of respirable size and therefore whether they have the potential to reach the alveoli of an indicated patient’s lungs;
should require Neurelis to quantify the amount of vitamin E reaching the alveoli if FDA determines that the vitamin E has that potential to reach it; and
should require Neurelis to include appropriate labeling for Valtoco based on the studies being requested, given the concern for vitamin E and its effects on an individual’s lungs when inhaled in an aerosolized form.

FDA rejected all of the petition’s claims and requests, saying it did not agree with the assertions and conclusions stated in the petition.

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

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome