Will PPC injections make a comeback? MFDS review underway

Application submitted for soybean phosphatidylcholine as a localized fat reduction agent

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PPC (phosphatidylcholine) injections, which dominated the aesthetic and obesity market in the late 2000s but subsequently disappeared, are preparing for a spectacular comeback with a formal marketing authorization in hand. In the past, PPC injections were approved as an adjunct treatment for hepatic coma caused by liver cirrhosis, but they became controversial due to their widespread "off-label" use for fat reduction.

According to industry sources on the 9th, the Ministry of Food and Drug Safety (MFDS) recently initiated a Good Clinical Practice (GCP) inspection regarding the application for a change in product approval for "Amiraju Inj. 5mL," a PPC-based drug. The GCP inspection is a critical final hurdle where the MFDS verifies the reliability of clinical data just before granting drug approval. This implies that the MFDS has entered the final stages of the product approval review.

Amipharm has been known to have applied for approval. The company has developed a proprietary formulation technology that completely eliminates surfactants and utilizes only pure soybean-derived phosphatidylcholine (PPC) to induce the "apoptosis" (programmed cell death) in fat cells. Unlike earlier formulations that forcibly caused cell necrosis, the new composition selectively induces the death of fat cells only, thereby significantly reducing pain and swelling while maintaining a semi-permanent fat reduction effect.

Amipharm successfully completed a domestic Phase III clinical trial involving 252 patients with submental (double chin) fat, demonstrating a high improvement rate of approximately 73.7%. Following this, the company applied for formal product approval as a ‘localized fat reduction agent’ and is known to be s proceeding simultaneously with manufacturing license approval procedures.

PPC injections like Lipobin Inj were originally approved as prescription drugs for the treatment of hepatic coma associated with liver cirrhosis. However, rumors that American pop star Britney Spears had lost weight using PPC injections fueled a craze in aesthetic clinics and plastic surgery practices, where the products were widely prescribed off-label to reduce fat under the chin and in the upper arms.

The product's popularity, however, did not last. Manufacturers ultimately failed to demonstrate post-marketing efficacy for the originally approved indication of hepatic coma, while growing criticism over the indiscriminate use of PPC injections as obesity treatments further intensified. As a result, the products were eventually withdrawn from the Korean market.

An industry official commented, “It is highly meaningful that PPC, a substance that once disappeared from the aesthetic market, is returning as a formally approved therapeutic product after demonstrating its safety. If the MFDS inspection proceeds smoothly, official marketing authorization is certainly within reach.”