Both Novo Nordisk (NYSE:NVO) and Sanofi (NYSE:SNY) said yesterday that they won FDA approval for pre-filled pens with drug combinations indicated for adults with Type II diabetes.
Paris-based Sanofi’s Soliqua 100/33 is an injectable medicine composed of 2 diabetes drugs – insulin glargine and lixisenatide. The drug is approved for adults with Type II diabetes not controlled with less than 60 units daily of long-acting basal insulin or lixisenatide. The pre-filled pen will be available in U.S. retail pharmacies in January, according to Sanofi.
In 1 study, Soliqua lowered average blood sugar better than Sanofi’s Lantus insulin glargine injection in the majority of 736 patients. Patients who used Soliqua experienced similar rates of documented hypoglycemia compared to those who received Lantus. The most frequently reported adverse events were hypoglycemia, nausea, nasopharyngitis, diarrhea and upper respiratory tract infection.
The combination device was submitted for review in 10 markets, including the EU. The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the approval of the product earlier this month.
“Sanofi continues to be a pioneer in developing diabetes therapies and in bringing forward new treatment options for the approximately 50% of patients whose blood sugar levels remain uncontrolled on daily basal insulin,” president of global R&D Dr. Elias Zerhouni said in prepared remarks. “Soliqua 100/33 is an alternate new approach that can help adults living with type II diabetes uncontrolled on basal insulin or lixisenatide to reach their treatment goal.”
Denmark’s Novo Nordisk said the FDA approved its New Drug Application for Xultophy, a once-daily injection of a combination of Tresiba (insulin degludec) and Victoza (liraglutide), designed to improve glycemic control in adults with Type II diabetes that is not well controlled with less than 50 units of basal insulin daily or liraglutide.
In 3 trials, enrolling a total of 1,393 Type II diabetics, patients who switched to Xultophy had reductions in blood sugar. The most common adverse events seen during clinical evaluation were nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection.
The company reported that it expects a U.S. launch in the 1st half of next year. It also said it will offer a savings card for eligible patients with commercial insurance to reduce their co-pay.
“Novo Nordisk is committed to discovering and developing new medicines, like Xultophy 100/3.6, that may make a difference in the way some adults with type 2 diabetes manage their diabetes and achieve their treatment goals,” executive VP & North American operations head Jakob Riis said in prepared remarks. “Combining Tresiba and Victoza into a single injection will offer patients a new option that may help control their blood sugar. We look forward to making Xultophy 100/3.6 available to adults with type 2 diabetes in the 1st half of 2017.”
