Last Updated on December 21, 2024 by The Health Master
USFDA
Zealand Pharma, a Danish biotech company, has faced another setback in its quest to bring their drug, dasiglucagon, to the U.S. market. The U.S. Food and Drug Administration (USFDA) has rejected the drug for the second time, citing concerns related to a third-party manufacturing facility.
USFDA’s Decision and Concerns
In a “complete response letter,” the USFDA indicated that the timing of a reinspection at the third-party manufacturing facility was a primary factor in their decision.
Notably, the USFDA did not raise any concerns about the clinical data or safety profile of dasiglucagon.
Dasiglucagon: A Potential Treatment for a Rare Genetic Disorder
Dasiglucagon is designed to treat congenital hyperinsulinism (CHI), a rare genetic disorder affecting approximately 1 in 50,000 newborns.
CHI causes abnormally high insulin levels, leading to frequent episodes of low blood sugar or hypoglycemia.
Zealand Pharma’s Next Steps
Despite the USFDA’s rejection, Zealand Pharma remains committed to bringing dasiglucagon to U.S. patients.
The company plans to work closely with the USFDA and the third-party manufacturer to address the regulatory concerns and resubmit the drug for approval.
USFDA’s Request for Additional Data
The USFDA has requested additional data for the use of dasiglucagon beyond three weeks of dosing. Zealand Pharma expects to submit this data by the end of 2024.
The Impact of the USFDA’s Decision
The USFDA’s rejection of dasiglucagon is a significant setback for patients with CHI and their families who have been eagerly awaiting a potential treatment.
However, Zealand Pharma’s commitment to the drug and its ongoing efforts with the USFDA offer hope for future approval.
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