Medytox has encountered a significant setback as the U.S. FDA has declined the biologics license application (BLA) for its innovative non-animal liquid botulinum toxin product, MT10109L, aimed at reducing moderate to severe glabellar (forehead) and lateral canthal (crow's feet) lines.

The refusal, dated last Saturday, was primarily due to the absence of specific validation test reports related to MT10109L, hindering the approval process.

The company had previously submitted the BLA last December based on the completion of five large-scale global phase 3 clinical trials of MT10109L in February of that year, involving 1,300 patients in the U.S., Canada, and European medical institutions.

According to Medytox, the submission marked the world's first to successfully apply for product approval for such a liquid toxin formulation, as there are no liquid toxin formulations in the U.S.

Medytox has expressed its intention to engage in discussions with the FDA to address and rectify the cited deficiencies. The company plans to resubmit the application after thorough consultation and resolution of the outstanding issues, with a commitment to update the public and investors promptly upon finalization.

"The FDA typically commences the review process two months after submission to verify the completeness of the documents," a Medytox official told Korea Biomedical Review. "However, Medytox was informed of the document shortfall."

The company has opted for discretion in public disclosures to avoid any speculation and potential misinformation, he added.

However, the official did not disclose what documents were cited as lacking by the FDA.

When queried about the future timeline for resubmission and approval, the company stated that there is no definitive timeline available at this moment. The company's immediate focus is on complementing the necessary documentation as swiftly as possible, mindful of the critical nature of timely compliance with regulatory requirements.