Product Approval Summaries

BIOLOGICS

FDA has approved an Amgen supplemental BLA for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The company says this indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials.

Genmab has received FDA approval of a supplemental BLA for the use of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for treating patients with relapsed chronic lymphocytic leukemia. The submission, which was given a priority review in May, was submitted by Novartis under a collaboration between the two companies.

FDA has approved a Sandoz BLA for Erelzi, (etanercept-szzs) a biosimilar copy of Amgen’s Enbrel (etanercept), indicated for treating rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

Seqirus has received FDA approval of its Afluria Quadrivalent (Influenza Vaccine) for use in persons 18 years of age and older. Afluria is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

DEVICES

FDA has approved a Medtronic PMA for the Enlite sensor for use with the iPro2 Professional Continuous Glucose Monitoring system. The disposable device can be worn up to six days, and like a holter monitor for cardiovascular care it records a patient’s glucose levels 24 hours a day. “Used intermittently, the iPro2 system provides physicians with insights into how the nutrition plan, medication regimen and daily activities affect glucose levels of people with diabetes, enabling them to know more about their patients’ glucose profile in less time and helping them to make more informed decisions regarding diabetes management,” the company says.

FDA has cleared a Siemens 510(k) for the Somatom Drive computed tomography system, a new dual source scanner designed to deliver precise imaging while reducing patient dose exposure. The device is equipped with the company’s Straton MX Sigma X-ray tubes and Sigma generators, which allow for more targeted beam focusing and enable examinations using high energy levels at low voltages, the company says. “These lower voltages may allow clinicians to use less contrast, which can be burdensome for patients who are seriously ill or have reduced kidney function,” it says. “And because the X-ray tube voltages of the Somatom Drive are adjustable in 10 kV increments ranging from 70 kV to 140 kV, clinicians can tailor the voltage and, therefore, the dose to each patient. Scanning at a lower kV level reduces patient radiation exposure.”

HUMAN DRUGS

Medicure Inc. has received approval from FDA for its new “bolus vial” product format for Aggrastat (tirofiban HCl). The new format is a concentrated, pre-mixed, 15 ml vial designed specifically for convenient delivery of the Aggrastat bolus dose (25 mcg/kg). Aggrastat is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome.