Product Approval Summaries

BIOLOGICS

FDA has approved Amgen’s Amjevita, a biosimilar copy of Abbott’s Humira (adalimumab) for multiple inflammatory diseases. This is FDA’s fourth approved biosimilar.

DEVICES

FDA has approved a Med-El USA PMA for the Synchrony EAS (Electric Acoustic Stimulation) Hearing Implant System. The device combines two technologies — a Synchrony cochlear implant that stimulates the auditory nerve for high-frequency hearing loss, and the Sonnet EAS audio processor, with built-in acoustic amplification for low-frequency hearing loss. “The EAS System has the potential to close the gap for people who have high-frequency hearing loss, but whose residual low-frequency hearing would have made them ineligible for a cochlear implant up until now,” the company says.

Approval has been granted to Bayer for its Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg, a progestin-containing intrauterine system for preventing pregnancy for up to five years. Kyleena is a small, flexible plastic T-shaped device containing levonorgestrel 19.5 mg. It is placed by a healthcare provider during an in-office visit. “Because Kyleena slowly releases levonorgestrel into a woman’s uterus, only small amounts of the hormone enter the blood,” Bayer says.

FDA has cleared a GI View Ltd. 510(k) for its new Aer-O-Scope Colonoscope System, a disposable, self-propelled, joystick-controlled, colonoscope that features therapeutic access. “The new system has two working channels that enable therapeutic access using standard tools, such as snares and forceps, to take biopsies or perform polypectomies,” the company says.

Heidelberg Engineering has received 510(k) clearance to market its Spectralis OCT Glaucoma Module Premium Edition that is intended to provide a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer by precisely matching unique scan patterns to the fine anatomic structures relevant in glaucoma diagnostics. The company says the device uses a new proprietary technology called the Anatomic Positioning System that creates an anatomic map unique to each patient’s eye using two fixed, structural landmarks — the center of the fovea and the center of Bruch’s membrane opening.

FDA has cleared a Life Spine 510(k) for the PRO-LINK Ti Stand-Alone Cervical Spacer System, a stand-alone cervical interbody that is made using the company’s Osseo-Loc technology. Osseo-Loc is a proprietary surface treatment for titanium with 500-600 microns of porosity, which is intended to help create an environment for potential bone growth, the company says.

FDA has cleared a K2M Group Holdings 510(k) for screw and connector components for a spine application used with its MESA Spinal System. The company says this clearance enables the screw and connector components to be used as a part of a growing rod construct designed to accommodate growth in patients under ten years of age. “With this growing spine application, surgeons can utilize components from a traditional fusion construct for a growth-enabling construction, allowing implants to be surgically lengthened on a periodic basis as the patient grows,” K2M says. It also offers a growth guidance option, combining standard instrumentation and placement of unlocked closed-head screws at non-fusion levels to allow for rod passage as the patient grows.

DRUGS

FDA has approved a Janssen Pharmaceuticals supplemental NDA for Invokamet XR (canagliflozin and metformin hydrochloride) for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes when treatment with the two medications is appropriate. The new indication aligns with current treatment guidelines from the American Association of Clinical Endocrinologists and American College of Endocrinology and from the American Diabetes Association.

FDA has approved Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys 51 (eteplirsen) under the agency’s accelerated approval process.