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Novo Nordisk Korea unveils diabetes drug Fiasp in Korea
  • By Lee Han-soo
  • Published 2019.03.19 17:37
  • Updated 2019.03.19 17:37
  • comments 0

Novo Nordisk Korea celebrated the launch of Fiasp, its rapid-acting mealtime insulin, in a news conference Thursday. The introduction of the drug in Korea marks its first launch in Asia.

Novo Nordisk Korea CEO Rana Azfar Zafar celebrates the launch of Fiasp in Korea, in a news conference at JW Marriott Hotel in Seoul Tuesday.

Fiasp is a new insulin drug that allows for safe, effective control of blood glucose rising rapidly after meals. The additions of vitamin B3 (niacinamide) and L-arginine amino acid to existing fast-acting insulin (Novo Rapid) makes the initial action twice as fast

The drug is also the first fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation, while patients can administer Fiasp at the beginning of a meal or within 20 minutes after starting a meal.

Pharmacokinetic (PK/PD) clinical results on insulin pumps showed that the initial onset of action was five minutes faster than that of the conventional fast-acting insulin within 30 minutes after administration, resulting in the twice faster start of the action.

During the news conference, the company presented various “ONSET” clinical trials that ultimately allowed the Novo Nordisk to receive approval for the drug.

The ONSET 1 study on 1,143 patients with type-1 diabetes showed a significant glycemic control effect compared to insulin aspart and a substantial reduction in post-meal blood glucose levels.

Also, the results of phase 3 ONSET studies evaluated the efficacy and safety of Fiasp on 689 patients with type 2 diabetes, while the results from the ONSET 2 study showed blood glucose control effect to be comparable to insulin aspart as well as a significant improvement in post-meal blood glucose. The ONSET 8 study showed that Fiasp had similar blood glucose control effects in both pre- and post-meal doses compared to Novo Rapid.

“We are delighted to be able to offer upgraded treatment options to Korean diabetics who are having difficulty regulating postprandial blood glucose through the launch of Fiasp,” Novo Nordisk Korea CEO Rana Azfar Zafar said. “As a global leader in the field of diabetes care, Novo Nordisk will continue to work to ensure that patients benefit from extensive and improved treatment at the right time with effective treatment options.”

Novo Nordisk also plans to file for a label update for Fiasp to the Ministry of Food and Drug Safety seeking approval for use in children and adolescents in the future. The company applied for the label update in the U.S. and EU earlier this month.

“We anticipate a response from the European Medicines Agency later this year and from the U.S. Food and Drug Administration in early 2020,” said Vinay Prusty, director of clinical development, medical affairs, regulatory and quality at Novo Nordisk. “After receiving approval, we plan to apply for the label update in Korea.”

Considering it usually takes four to six months to receive approval from the Korea regulatory agency, the company expects to expand indications for the drug in the first half of next year, he added.

The therapy has won the go-ahead from the European Commission (EC) and more than 37 other countries, including the United States, Canada, and the United Kingdom.

corea022@docdocdoc.co.kr

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