Once-weekly Icodec nears approval in Korea

MFDS's Central Pharmaceutical Affairs Council discusses the safety and efficacy of basal insulin preparation

A once-weekly insulin drug for diabetics is close to being approved in Korea.  According to the minutes of the Central Pharmaceutical Affairs Council meeting released by the Ministry of Food and Drug Safety (MFDS) on the 21st, the safety and efficacy feasibility of the basal insulin preparation was discussed.

 

As a result of the deliberation, the council recognized the safety and efficacy of the preparations, based on which a risk management plan for hypoglycemia management will now be required.

 

The drug being discussed was Novo Nordisk's Icodec, a fixed-dose combination of a once-weekly GLP-1 RA Ozempic (semaglutide, Novo Nordisk) contained in a pen at a ratio of 1 unit to 0.0029 mg.

 

Icodec was developed as the first once-weekly formulation of basal insulin with potent hypoglycemic effects and had demonstrated non-inferiority to the existing once-daily formulation of basal insulin.

 

The CPAC members noted that although Icodec’s clinical results in patients with type 1 diabetes were positive, there was a need for management to reduce hypoglycemic episodes.

 

Patients whose blood glucose is not controlled with insulin and require insulin intensification therapy, which involves the addition of mealtime bolus doses of insulin, are at increased risk of increased injection frequency, hypoglycemia, and weight gain.

 

Regarding such concern, a council member said, “Although the incidence of hypoglycemic episodes tended to be higher than in the control group, the safety profile was as expected for the basal insulin and there was no increase in hypoglycemic episodes over the entire study period.

 

The management of hypoglycemic episodes with existing once-daily long-acting insulin formulations in practice is not a major concern and is manageable for the item under review.” In other words, as the drug’s clinical results showed that all patients did not have recurrent hypoglycemic episodes, the CPAC deemed the risk as manageable.

 

There were also mentions about the convenience of once-weekly dosing versus lifelong injections.

 

“A long-acting formulation would be very helpful in terms of patient convenience and adherence,” said another member, explaining that “This is similar to the use of long-acting osteoporosis medications that have extended dosing intervals.” In terms of improving adherence, some pointed out that the once-weekly injections would be of great benefit to patients.

 

“While we agree with the safety and efficacy rationale, the risk of hypoglycemic episodes with this drug should be emphasized in the patient information leaflet to ensure that the risk of hypoglycemic episodes and risk mitigation measures are not overlooked in practice,” said an official.

 

Regarding the same concern, another committee member commented “Fatty acid-binding long-acting peptide formulations are already available in the form of once-daily Tresiba, which has been used as basal insulin for about 10 years without any major issues.” “Overall, all members of the committee agree on the item’s safety and efficacy,” the CPAC chairman concluded, ”However, we would like to emphasize the need for caution for hypoglycemic episodes in the instructions for use submitted by the company.” Meanwhile, in July, the U.S.

 

Food and Drug Administration (FDA) put Icodec's approval on hold, stating the need to address issues with the manufacturing process and labeling related to its type 1 diabetes indication.