FDA approves first continuous glucose monitoring system that does not require fingerstick test
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved its first continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation via a traditional fingerstick test. The FDA announced it expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.
The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.
"The FDA works hard to help ensure that novel technologies, which can reduce the burden of daily disease management, are safe and accurate," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions. This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their health care providers about the use of real-time continuous glucose monitoring in diabetes management."
The G5 Mobile Continuous Glucose Monitoring System uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels. Real-time results are sent wirelessly every five minutes to a dedicated receiver and a compatible mobile device running a mobile app. Alarms and alerts indicate glucose levels above or below user-set thresholds. The system measures glucose in fluid under the skin and must be calibrated at least two times per day using blood obtained from fingerstick tests. However, additional daily fingerstick blood tests are generally no longer necessary because unlike other continuous glucose monitoring systems, results from this device can now be used directly by patients to make diabetes treatment decisions without confirmation from a traditional fingerstick test, stated the FDA.
According to the U.S. Centers for Disease Control and Prevention, more than 29 million people in the U.S. have diabetes.
Walgreens expands availability of naloxone without a prescription
DEERFIELD, Ill. — Walgreens has expanded the availability of prescription-free naloxone to 33 states and the District of Columbia.
The medication can be dispensed in accordance with each state’s pharmacy regulations at nearly 5,800 Walgreens pharmacies. Naloxone can be used in the event of an overdose to reverse the effects of heroin or other opioid drugs, and is administered by injection or nasal spray.
“By making naloxone available without a prescription, we are making it easier for families and caregivers to help their loved ones by having it on hand in case it’s needed,” said Rick Gates, Walgreens group vice president of pharmacy. “As a pharmacy we are here to help people, and we are committed to making naloxone more accessible in the communities we serve.”
Walgreens will continue make the medication available in more states without a prescription. By early 2017 the company plans to begin offering naloxone without requiring a prescription in Arkansas, California, Connecticut, Iowa, Kentucky, Nevada and Tennessee.
States where Walgreens offers naloxone without requiring a prescription:
Alabama, Colorado, District of Columbia, Florida, Idaho, Illinois, Indiana, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York (including Duane Reade pharmacies), North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Vermont, Virginia, Washington, West Virginia and Wisconsin.
Janssen seeks approval of Simponi Aria for psoriatic arthritis and ankylosing spondylitis
HORSHAM, Pa. — Janssen Biotech submitted two Supplemental Biologics License Applications to the U.S. Food and Drug Administration seeking approval of its Simponi Aria (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis. Psoriatic arthritis and ankylosing spondylitis are chronic, systemic inflammatory conditions that combined affect more than 2 million Americans.
"At Janssen, we are committed to addressing the unmet medical needs of patients living with psoriatic arthritis and ankylosing spondylitis through the discovery and development of innovative therapeutics," said Newman Yeilding, M.D, head of Immunology Development, Janssen Research and Development. "We understand the need for additional treatment options for patients and their healthcare providers and hope to make Simponi Aria available for those in need."
Simponi Aria is an infusible, fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. It is currently approved as a 30-minute intravenous infusion for the treatment of adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate.
According to Horsham-based Janseen Biotech, data from two separate Phase 3 studies evaluating the efficacy and safety of Simponi Aria 2 mg/kg given as an intravenous infusion every eight weeks after two starter doses at weeks zero and 4 in the treatment of adults living with active psoriatic arthritis (GO-VIBRANT) and active ankylosing spondylitis (GO-ALIVE) served as the basis for the submissions.
Simponi Aria is an infusible, fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.