USFDA declines to approve this weekly Insulin

The delay in icodec's US approval is a setback for both Novo Nordisk and patients seeking a more convenient insulin treatment option.

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Medicine red round tablets making sign of cross reject or decline
Picture: Pixabay

Last Updated on July 12, 2024 by The Health Master

Insulin

In a move impacting the diabetes treatment landscape, the US Food and Drug Administration (USFDA) has requested additional information from Novo Nordisk concerning its once-weekly basal insulin icodec.

This news, announced by the Danish drugmaker, delays potential wider availability of the treatment in the United States.

USFDA Seeks Clarification

The USFDA issued a “complete response letter” to Novo Nordisk, outlining its need for further data on two key areas:

  • Manufacturing Process: The regulatory body requires more details regarding the production of icodec to ensure it meets stringent quality and safety standards.
  • Type 1 Diabetes Indication: Concerns were raised about the use of icodec in patients with Type 1 diabetes, specifically regarding the potential for hypoglycemia (low blood sugar) events.

Next Steps

Novo Nordisk acknowledged the USFDA’s requests and stated they would not be able to address them entirely within 2024.

The company remains committed to collaborating with the USFDA to determine the necessary steps for approval and bring icodec to patients in the US.

Background

Icodec, if approved, would represent a significant advancement in diabetes management.

By offering a once-weekly injection compared to the current standard of daily or multiple daily injections, icodec has the potential to improve treatment adherence and quality of life for patients.

However, the USFDA’s decision reflects some of the concerns raised during the application review process.

An external panel previously expressed reservations regarding the use of icodec in Type 1 diabetes due to potential blood sugar fluctuations.

Global Availability of icodec

While the US approval process faces a hurdle, it’s important to note that icodec has received approval under the brand name Awiqli in other regions, including Europe, Canada, Japan, and Australia.

This suggests that Novo Nordisk remains confident in the drug’s efficacy and safety profile.

Looking Ahead

The delay in icodec’s US approval is a setback for both Novo Nordisk and patients seeking a more convenient insulin treatment option.

It also highlights the USFDA’s rigorous approach to ensuring medication safety and efficacy.

While the timeline for US availability remains uncertain, Novo Nordisk’s commitment to working with the USFDA offers hope for a future approval.

In the meantime, patients with diabetes should continue to follow their current treatment plans as directed by their healthcare providers.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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