Express Pharma

US FDA approves Acer Therapeutics’ genetic disorder drug

The approval letter, issued recently, said the drug, sodium phenylbutyrate, could be used as an adjunctive therapy to the standard of care for patients with UCDs with certain deficiencies

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The US Food and Drug Administration (FDA) has approved Acer Therapeutics’ drug for treating patients with a type of genetic disorder called Urea Cycle Disorders (UCDs), according to the health regulator’s website.

The approval letter, issued recently, said the drug, sodium phenylbutyrate, could be used as an adjunctive therapy to the standard of care for patients with UCDs with certain deficiencies.

UCD is a genetic condition that causes toxic ammonia to build up in the blood due to the deficiency of certain enzymes.

The company resubmitted its marketing application for the drug in July after it got the so-called complete response letter from FDA in June.

Edits by EP News Bureau

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