Product Approval Summaries

DEVICES

FDA has approved a Medtronic PMA for its Azure pacemakers with BlueSync technology. The devices are available in both single chamber and dual chamber models, and offer improved longevity, estimated at 13.7 years, according to the company. The new pacemakers also allow patients to have magnetic resonance imaging scans in either 1.5 or 3 Tesla machines, it says. Additionally, Medtronic says the BlueSync technology allows wireless and secure remote monitoring through its CareLink Network, which includes access restrictions to protect integrity of device functionality and end-to-end encryption to protect patient data.

FDA has cleared a Voluntis 510(k) for Insulia, a “digital companion” for people with Type 2 diabetes that the sponsor says can integrate Lilly’s Basaglar and Novo Nordisk’s Tresiba insulin products. According to the company, this now makes Insulia available for people using any brand of basal insulin including Lantus, Levemir, Toujeo, Tresiba and Basaglar. Voluntis says it is planning to make Insulia available for other insulin therapies, including NPH insulin and GLP-1/basal insulin combinations sometime next year.

FDA has cleared an Alcyone Lifesciences 510(k) for the Alivio Ventricular Catheter and Flusher System for treating hydrocephalus. The device is intended to provide clinicians with the option of non-invasive retrograde flushing of the ventricular catheter, to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid (CSF) flow in a non-flowing shunt. Hydrocephalus is a condition in which an excess of CSF accumulates within the ventricles and increases pressure in the brain, resulting in a life-threatening situation.  CSF shunts are implantable devices inserted by neurosurgeons to treat hydrocephalus.

DRUGS

FDA has approved Pfizer’s Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer returning after a kidney has been removed. Sutent is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It was first approved in 2006 for treating certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma. It is also approved for certain pancreatic cancer patients.

FDA has approved Genentech’s Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (Stage II bulky, III or IV). Approval is based on results from the Phase 3 GALLIUM study, which showed superior progression-free survival for patients who received the Gazyva-based regimen compared with those who received a Rituxan (rituximab)-based regimen as an initial (first-line) therapy.

FDA has accepted an Alkermes NDA for aripiprazole lauroxil nanocrystal dispersion (ALNCD) as an add-on therapy with its Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophrenia. The agency has set a 6/30/2018 user fee review target action date for the submission. “If approved, administration of ALNCD in conjunction with a single oral dose of 30 mg aripiprazole will replace the need for three weeks of concomitant oral aripiprazole with the first dose of Aristada,” the company says.