Drugs

Guide on ‘Wet Age’ Macular Degeneration Drugs

FDA has released a draft guidance entitled “Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.” The document provides recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and improve efficiencies in drug development programs.

The guidance recommends a parallel-group, randomized by patient, double-masked trial design in which the investigational drug group demonstrates superiority over the control group. Trials should include patients aged 50 and older who have choroidal neovascularization documented by fundus photography, fluorescein angiography, or optical coherence tomography. “For a trial designed as a superiority trial, the sponsor should enroll patients with neovascularization caused by age-related macular degeneration who have had visual loss or would be expected to develop visual loss,” it says.

Regarding efficacy considerations, FDA says one eye per patient should be prespecified as the study eye for the purposes of the efficacy assessment even if both eyes are treated. The guidance includes several primary endpoint measurement options, such as “a statistically significant smaller percentage of patients with a doubling of the visual angle in best corrected distance visual acuity at nine months or later after the start of drug administration in the investigational drug treatment group compared to the control group.”

To fulfill safety data objectives, the document recommends 400 or more patients using the investigational drug at a dose at least as high as that proposed for marketing. It also says that before submitting an NDA, patients should have completed at least nine months of follow-up after treatment initiation. Additionally, FDA recommends that at least one concurrently controlled safety trial be conducted for at least two years.

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