- In February 2023, Zydus Group obtained final approval from the U.S. Food and Drug Administration (FDA) for Sirolimus Tablets, 1 mg, and 2 mg (generic for Rapamune Tablets). This approval reinforced Zydus's product portfolio and market position, enabling the company to provide a vital medication for preventing organ rejection in kidney transplant recipients, enhancing affordability and access
- In January 2024 (published February 2024), a prospective clinical trial demonstrated the efficacy of Sirolimus in treating intractable lymphatic anomalies (LAs). This open-label, single-arm, multicenter study conducted in Japan showed that Sirolimus can reduce lymphatic tissue volume in LAs and may lead to improvements in clinical symptoms and quality of life. This highlights the ongoing expansion of Sirolimus's applications in rare and complex diseases beyond its traditional uses
- In April 2022 (with ongoing impact into 2023-2024), the FDA approved topical Sirolimus (HYFTOR) for facial angiofibroma associated with tuberous sclerosis complex. This marked the first topical treatment approved in the US for this specific manifestation. While the approval was earlier, its market adoption and the ongoing clinical experience continue to shape the Sirolimus landscape, highlighting the potential for localized formulations.
