The U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for YY003, the first liquid formulation of recombinant botulinum toxin type A (BoNT/A) delivered in a prefilled syringe. The product was developed by Claruvis Pharmaceutical Co., a subsidiary of MingMed Biotechnology, for the treatment of moderate to severe glabellar lines. This approval enables the company to proceed with clinical trials in the United States, according to a press release from PR Newswire.

Claruvis recently completed a phase III clinical trial for glabellar lines in China, where all study endpoints were met. In addition to the U.S. IND approval, the company is also conducting a phase II trial in China for the treatment of adults with upper arm spasms. Claruvis has initiated a Biologics License Application (BLA) in China, supported by successful results from phase I, II, and III clinical studies.

The liquid formulation, packaged in a pre-filled syringe, is intended to provide a ready-to-use option for BoNT/A administration. The FDA’s approval of the IND is viewed as a step toward future clinical development and potential market entry.

Reference:

MingMed Biotechnology. The world's first liquid formulation of recombinant botulinum toxin type A has obtained IND approval by the FDA. PR Newswire. September 25, 2024. Accessed September 25, 2024. https://www.prnewswire.com