Novo Nordisk (NYSE:NVO) said today that the European Union’s Committee for Medicinal Products for Human Use issued a positive opinion on its fast-acting insulin analogue, Fiasp. The Danish company also committed to expanding its Changing Diabetes in Children program, which provides access to diabetes care and free insulin to children with Type I diabetes in developing countries.
The committee, under the European Medicines Agency, recommended marketing authorization for adults withType I and Type II diabetes. Fiasp is a fast-acting mealtime insulin that has a greater glucose-lowering effect than Nordisk’s NovoRapid insulin. The committee recommended that the European Commission indicate Fiasp for use as the bolus component of basal-bolus therapy in combination with basal insulin and for insulin infusion using an insulin pump.
“We believe Fiasp provides an important evolution in mealtime insulin, which can address the unmet medical need for people requiring further improved blood glucose control around meals or flexibility of dosing,” executive VP & CSO Mads Krogsgaard Thomsen said in prepared remarks.
Nordisk said it expects to receive final authorization from the European Commission in the 1st quarter of 2017.
The company also said it will continue its Changing Diabetes in Children program for 4 years, expanding the program to including Cambodia, Ivory Coast, Myanmar, Senegal and Sudan. Nordisk anticipates that by 2020, more than 20,000 kids will have benefited from the program.
Since the program started in 2009, nearly 14,000 kids across 9 countries in Africa and South-East Asia have received free human insulin and access to diabetes care.
“The Changing Diabetes in Children program has been iconic,” Professor Azad Khan, president of the Diabetic Association of Bangladesh, explained. “It has changed the lives of children with type 1 diabetes in Bangladesh. Their survival depends on the supply of insulin as well as education on how to cope with diabetes, and the program provides all of this.”
“The provision of free medicine alone doesn’t solve complex healthcare challenges,” president & CEO Lars Rebien Sørensen added. “From the outset of this program, we have therefore worked closely with local partners to deliver sustainable solutions alongside insulin to improve the lives of children with type 1 diabetes both now and in the future.”