Foresee Pharmaceuticals Sets PDUFA Goal Date for CAMCEVI's 3-Month Injectable Formula

Foresee Pharmaceuticals, a prominent biopharmaceutical entity based in Taiwan, has officially announced a pivotal milestone concerning its 3-month injectable formulation of CAMCEVI (leuprolide mesylate). The U.S. Food and Drug Administration (FDA) has provided a Day-74 letter, signaling that the Prescription Drug User Fee Act (PDUFA) goal date for this medication is set for August 29, 2025. This news marks a significant advancement in the regulatory pathway for this important treatment.

The announcement comes straight from Dr. Ben Chien, Founder and Chairman of Foresee. He expressed enthusiasm regarding this pivotal regulatory milestone, stating, "With the PDUFA goal date now established, we are eager to collaborate closely with the FDA throughout the regulatory process. Our objective is to move this treatment option closer to potential approval and successful market launch. This will allow us to offer patients an innovative 3-month formulation of CAMCEVI, complementing the existing 6-month version already available. Thus, Foresee will provide a complete and differentiated product range."

The 3-month CAMCEVI version is a long-acting injectable (LAI) specifically designed for adult patients battling advanced prostate cancer. The New Drug Application (NDA) submission was bolstered by the positive outcomes from a prior Phase 3 clinical study involving 144 participants with advanced prostate carcinoma. Results from this study demonstrated that administering the leuprolide mesylate injection every three months was not only effective but also safe and well-tolerated, with an impressive 97.9% of subjects achieving primary efficacy endpoints.

This promising formulation aims to provide an alternative to existing treatments and is anticipated to enhance the quality of life for patients as they manage this aggressive form of cancer. Foresee Pharmaceuticals has shown remarkable dedication to addressing the needs of patients in niche therapeutic areas, particularly those suffering from severe and unmet health issues. Currently, the company markets the CAMCEVI 42 mg variant, and its 6-month version is already authorized in several regions, including the U.S., Canada, the European Union, Taiwan, Israel, and the United Kingdom, with its U.S. launch taking place in April 2022.

In addition to its potential for prostate cancer treatment, Foresee is keenly pursuing ongoing studies for CAMCEVI's applicability for central precocious puberty (CPP)—a condition that affects children's development. The Casppian Phase 3 clinical study is ongoing to evaluate CAMCEVI's efficacy in this context.

Furthermore, Foresee Pharmaceuticals has an extensive pipeline that includes various innovative therapies utilizing their specialized Stabilized Injectable Formulation (SIF) technology. This includes intriguing offerings such as Aderamastat (FP-025), an oral MMP-12 inhibitor, and Linvemastat (FP-020), both actively being investigated for their efficacy in treating rare and inflammatory diseases.

The concerted efforts of Foresee Pharmaceuticals reflect a commitment to addressing critical health challenges, as evidenced by their comprehensive, patient-centered approach to biopharmaceutical development.

As we approach the PDUFA goal date, the anticipation surrounding CAMCEVI's 3-month formulation increases, promising a new chapter for prostate cancer treatment options and signifying a vital step forward in the ongoing battle against this devastating disease. With the patient population in mind, Foresee Pharmaceuticals reiterates its dedication to providing safer, more effective treatment alternatives to enhance patients' lives on their health journeys.

For more information, visit Foresee Pharmaceuticals' website.