Product Approval Summaries
BIOLOGICS
CSL Behring has received FDA approval of Idelvion [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for treating hemophilia B. The company says Idelivion is the first factor IX therapy that delivers high-level protection with up to 14-day dosing in appropriate patients.
DEVICES
FDA has given Edwards Lifesciences expanded approval for its Sapien XT transcatheter heart valve for pulmonic valve replacement procedures. The approval covers treating adult and pediatric patients who suffer from either a narrowed pulmonary valve or moderate or greater pulmonary regurgitation caused by congenital heart disease. Expanded approval was supported by data from the multicenter COMPASSION clinical trial and additional clinical data from Europe, according to the company.
FDA has cleared an NEC Display Solutions of America 510(k) for the MultiSync MD211G5 medical-grade monitor for use in tomosynthesis applications and full field digital mammography. With a 21-inch display, the five-megapixel, grayscale monitor, which also has been cleared for standard mammography, “offers out-of-the-box factory DICOM calibration and uniformity control for consistent imaging across the entire screen,” the company says.
Philips Respironics has received FDA 510(k) clearance for the Care Orchestrator, a cloud-based clinical management software application for home use that “connects the portfolio of sleep and respiratory care enabling data, clinical management workflow, informatics and intelligence for providers, payers and patients within a single platform,” according to the company. The device was developed as part of Philips’ open cloud-based HealthSuite digital platform. Care Orchestrator is designed to interact with Philips’ sleep and respiratory devices, electronic medical records, insurance claims and billing systems and other Philips and third-party applications on the HealthSuite platform.
FDA has cleared a Tyber Medical 510(k) for its BioTy, a modified surface treatment for use on its Headless Screw System. “The technology modifies the surface characteristics of medical devices for advanced indications yet to be disclosed, but under development through the FDA review process,” the company says. In collaboration with Northeastern University, Tyber is conducting multiple studies on BioTy to analyze cellular response with the technology.
Zimmer Biomet Holdings has received FDA 510(k) clearance for the compatibility of the Nexel Total Elbow System with the Comprehensive Segmental Revision System (SRS). The distal component of the SRS humeral system when combined with Nexel is designed for elbow replacement, while the remaining components allow for proximal or total humeral reconstruction when used with the glenoid component of the Comprehensive Shoulder System, according to the company.
HUMAN DRUGS
FDA has approved Abbvie and Janssen Biotech’s Imbruvica (ibrutinib) capsules for treatment-naïve patients with chronic lymphocytic leukemia.1
FDA has approved an expanded indication for AstraZeneca’s Faslodex (fulvestrant), for combination use with palbociclib in treating women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. Single-therapy Faslodex has been approved since 2002 for treating postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy. “We believe that advances in cancer treatment will come, in part, from our research building upon existing treatments,” the company says.
Gilead Sciences has received FDA approval of an NDA for Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) for treating HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are made by Gilead Sciences, and rilpivirine made by Janssen Sciences Ireland UC. Odefsey is indicated as a complete regimen for treating HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. It is also indicated as a replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.