Product Approval Summaries

BIOLOGICS FDA has approved a CSL Behring BLA for Afstyla [antihemophilic factor (recombinant), single chain], a factor VIII single-chain therapy for adults and children with hemophilia A. The company says it is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing. In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualized spontaneous bleeding rate of 0.00, it says. Seqirus has received FDA approval of Flucelvax Quadrivalent (influenza vaccine), the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. The company says the vaccine helps protect against the two influenza A viruses and two B viruses recommended by the World Health Organization and FDA for the current influenza season. DEVICES Avantis Medical Systems has received FDA 510(k) clearance for the Third Eye Panoramic device for use as a multi-use imaging product for colonoscopies. Previously cleared as a disposable device, the new clearance now allows the device to be marketed for use multiple times prior to disposal. Avantis Medical says the wide-view visualization device is designed to provide gastroenterologists improved colon access where cancers and pre-cancerous polyps may be hidden from the view of a traditional colonoscope alone, such as behind folds. The Third Eye contains two video cameras that are directed laterally from its left and right sides, according to the company. It is attached to the tip of the colonoscope at the beginning of the procedure, and can be used during both the insertion and withdrawal phases. FDA has cleared Interventional Spine’s 80 Lumbar Lordotic Opticage Expandable Intervertebral Body Fusion Device. The company says the lumbar intervertebral body fusion device is indicated for use with autogenous bone graft in patients with degenerative disc disease at one or two contiguous levels from L2-S1. FDA has granted 510(k) clearance to Mauna Kea Technologies for its Confocal Miniprobes indicated for use in urological and minimally invasive surgical applications with the near-infrared Cellvizio platform. FDA has cleared a Perimeter Medical Imaging 510(k) for its OTIS 1.0 Optical Coherence Tomography System. The company says the device provides “high-resolution, real-time imaging of the periphery of excised tissue, enabling clinicians to visualize sub-surface structures up to 2 mm below the surface. These sub-surface structures would otherwise not be evident until days – and often weeks – later when conventional histology slides are available for review.” OTIS is indicated for use as an imaging tool in evaluating excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, Perimeter says. FDA has approved a Roche PMA for its cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients for monitoring CMV treatment. The company says the test was the first in vitro diagnostic test conforming to a WHO International Standard, making it possible for laboratories worldwide to obtain comparable results when testing for CMV. The standardized real-time polymerase chain reaction-based CMV test is designed for use on the automated COBAS AmpliPrep/COBAS TaqMan System, Roche says. Its DNA measurements can be used to assess virological response to antiviral treatment, it says. HUMAN DRUGS FDA has approved a Blue Earth Diagnostics NDA for Axumin, a radioactive diagnostic agent for injection, indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Approval was based on data from two studies. “The first compared 105 Axumin scans in men with suspected recurrence of prostate cancer to the histopathology (the study of tissue changes caused by disease) obtained by prostate biopsy and by biopsies of suspicious imaged lesions,” an agency release says. “The second study evaluated the agreement between 96 Axumin and C11 choline (an approved PET scan imaging test) scans in patients with median PSA values of 1.44 ng/mL.” Janssen Pharmaceuticals has received approval from FDA for its NDA supplement for Invokamet, a fixed-dose combination therapy of Invokana (canagliflozin) and metformin hydrochloride, for treating first-line adults with Type 2 diabetes. With this approval, Invokamet may now be marketed for use in adults with Type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy. The combination drug was approved in 2014 as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes who are not adequately controlled by either canagliflozin or metformin, or who are already being treated with both medications separately. FDA has approved a Titan Pharmaceuticals and Braeburn Pharmaceuticals NDA for Probuphine (buprenorphine), an implant for maintenance treatment of opioid dependence. The product is designed to provide a “constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program,” an FDA release says. Previously, buprenorphine was approved as a pill or a sublingual film. Vanda Pharmaceuticals has received FDA approval of a supplemental NDA for Fanapt, modifying and expanding the prescribing information (PI) to describe the effectiveness of Fanapt as a maintenance treatment for schizophrenia in adults. The new approved PI now includes placebo-controlled, long-term study data in which Fanapt was effective in delaying time to relapse in patients with schizophrenia who were stabilized on Fanapt up to 24 mg/day along with updating the safety section to reflect the larger clinical trial database.