FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a MicroVention PMA for the LVIS and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The low-profile visualized intraluminal support device features a braided conformable, resheathable and retrievable design that provides high metal coverage and end-to-end device visualization to support the smallest neurovascular embolization coils for treating wide-necked saccular intracranial aneurysms, according to the company. It has been approved for use in the U.S. under a Humanitarian Device Exemption since 2014.

FDA has approved HumanOptics’ CustomFlex artificial iris, the first standalone prosthetic iris in the U.S. An agency news release says the surgically implanted device treats adults and children whose iris is completely missing or damaged due to aniridia or other damage to the eye. The CustomFlex product is made of thin, foldable medical-grade silicone and is custom-sized and colored for each patient. Its safety and effectiveness were demonstrated in a non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects.

DRUGS

FDA has approved an Eli Lilly and Incyte NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. Approval is based on data from the RA-BEACON study, a randomized, double-blind, placebo-controlled study in 527 patients who had an inadequate response or intolerance to one or more TNF inhibitor therapies.

FDA has expanded the approval of Pfizer’s Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis, the first oral drug approved for chronic use in this indication. Other treatments must be administered through an intravenous infusion or subcutaneous injection, according to an agency release. Expanded approval is based on data from three controlled clinical trials. This included two eight-week placebo-controlled trials that demonstrated that 10 mg of Xeljanz given twice daily induces remission in about 18% of patients.

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