FDA Policy/General

Product Approval Summaries

BIOLOGICS

FDA has approved a Janssen Biotech BLA for Stelara (ustekinumab) for treating moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor blocker, or who failed or were intolerant to treatment with one or more TNF blockers.

DEVICES

FDA has approved Medtronic’s MiniMed 670G hybrid closed looped system, the first agency-approved device that is intended to automatically monitor glucose and provide appropriate basal insulin doses in people 14 years of age and older with Type 1 diabetes. The device, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administering or withholding insulin.

FDA has approved a label extension for Roche’s EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s Tagrisso (osimertinib), which is indicated for patients with metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer.

Abbott has obtained PMA approval for the FreeStyle Libre Pro system, a continuous glucose monitoring system for healthcare professionals to use with their diabetic patients. The device is intended to provide healthcare professionals with a visual snapshot of glucose data, known as the Ambulatory Glucose Profile. A round sensor is affixed to the back of the arm for up to 14 days, requiring no patient interaction with the device or the need for the patient to draw blood via a fingerstick to calibrate the sensor. It continuously measures glucose in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin.

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

Read more

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