Drugs

Advisors Suggest Narrower Desmopressin Indication

Members of the FDA Bone, Reproductive, and Urologic Drugs Advisory Committee voted 14-4 on 10/19 to recommend the safety and efficacy of Serenity Pharmaceuticals’ desmopressin nasal spray, but also recommended that the company’s proposed indication be narrowed. The committee members said that the proposed indication of treating adult onset nocturia was too broad and should be for adult nocturnal polyuria.

In materials provided to committee members, FDA medical reviewers said that nocturia is a symptom that can be caused by many conditions, some of which co-exist in the same patient; Serenity’s pivotal clinical trials limited enrollment to adults at least 50 years old, had numerous exclusion criteria, and had no restrictions on fluid intake; and the proposed indication did not specify age or underlying etiology.

All but one of the 18 committee members supported narrowing the indication to nocturnal polyuria or to idiopathic nocturnal polyuria. Some felt the indication should be restricted to patients over age 50 and that patients over age 75 should be excluded.

Committee members said that treatment effects at a 1.5 mcg dose were modest but still clinically meaningful, while they did not see efficacy in a lower 0.75 mcg dose. Some two-thirds of the committee members questioned the company’s proposed regimen of starting with 0.75 mcg nightly and titrating to 1.5 mcg nightly, if needed, after two to four weeks, citing a lack of proven favorable benefit-risk.

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