FDA approves two new diabetes drug treatments
SILVER SPRINGS, Md. — The Food and Drug Administration on Friday approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar control in adults with diabetes mellitus. Both Tresiba and Ryzodeg are manufactured by Novo Nordisk.
"Long-acting insulins play an essential role in the treatment of patients with Type 1 diabetes and in patients with Type 2 diabetes with advanced disease," said Jean-Marc Guettier,bdirector of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with Type 1 and Type 2 diabetes mellitus, with dosing based on the patient’s needs. Tresiba is administered subcutaneously once daily. In clinical trial participants with Type 1 and Type 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Tresiba provided reductions in HbA1c in line with reductions achieved with other long-acting insulin.
Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. In clinical trial participants with Type 1 and Type 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Ryzodeg 70/30 provided reductions in HbA1c equivalent to reductions achieved with other long-acting or pre-mixed insulin.
According to the FDA, Tresiba and Ryzodeg should not be used in those who have increased ketones in their blood or urine. The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.
According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes.
Mylan comments on Perrigo lawsuit
HERTFORDSHIRE, England, and PITTSBURGH — In the latest on the Mylan bid for Perrigo, Mylan on Thursday released a statement about the Perrigo lawsuit filed in Israel on Thursday.
The statement read:
“Mylan believes that the Perrigo suit filed in Israel [Thursday] is entirely without merit and that Mylan's offer in Israel is valid and proper in all respects.
“With that said, Perrigo's efforts are entirely futile, as all Perrigo shareholders — institutional and retail, including those in Israel — have always been free to switch their holdings at any time from the Tel Aviv Stock Exchange to the New York Stock Exchange, through a simple, fully automated, well-established system by notifying their broker. As a result, shareholders can participate fully in Mylan's compelling offer without regard to any lawsuits in Israel or any other frustrating actions pursued by Perrigo in Israel.
“Further, as Mylan has previously stated publicly, it has been our intent and desire to list Mylan's shares on the TASE to maintain liquidity in Israel for the convenience of those shareholders in Israel who prefer to trade on the TASE, and Mylan is already well-advanced in the process of submitting its application to the TASE and the Israel Securities Authority, and is committed to continuing to work closely with these parties to complete this process.”
Report: Pharmacists to increasingly learn alongside other health professionals
HAGUE, Netherlands — Learning together with other health professionals might become more mainstream for pharmacists, according to a report published Friday by the International Pharmaceutical Federation Education Initiative.
Interprofessional curriculums could become more common in classrooms and clinical settings, according to the report “Interprofessional education in a pharmacy context: Global report 2015.”
“As the number and complexity of treatments grow, it’s no longer possible for any one health provider — no matter how knowledgeable — to be able provide top quality care working in isolation,” said report co-author Tina Brock.
The report presented examples of multidisciplinary education from around the world, including the development of an interprofessional curriculum at the University of Queensland in Australia, and oncology nurses training in a hospital pharmacy department in Uruguay.
Interprofessional education may be an area of pharmacy where developing countries are active, using new models that others can replicate, according to the report. “In under-resourced countries, there is typically a shortage of health professionals. This provides additional motivation for professionals in emerging systems to combine forces,” Brock said.
“In the United States and many western systems, we’re now spending significant resource in retraining people who were educated separately to work together in high performing teams,” Brock continued. “If under-resourced countries never build those professional ‘silos’, they will not have to expend precious resource to tear them down.”
Pharmacists and educators will gather next week to discuss interprofessional education at the World Congress of Pharmacy and Pharmaceutical Sciences in Düsseldorf, Germany.