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Foresee Pharmaceuticals Celebrates FDA Approval of CAMCEVI ETM

Foresee Pharmaceuticals, a biopharmaceutical company with a focus on innovative treatment options, has recently achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting approval for CAMCEVI ETM. This new drug application (NDA) marks a critical moment not only for the company but also for patients suffering from advanced prostate cancer.

The Significance of CAMCEVI ETM

CAMCEVI ETM, formulated as a long-acting injectable (LAI) at 21 mg to be administered every three months, offers a solution to reduce the treatment burden on patients. Dr. Ben Chien, the founder and CEO of Foresee Pharmaceuticals, expressed his excitement and gratitude regarding this approval, emphasizing that it aligns with their mission to enhance the standard of care and improve the lives of patients.

The approval follows a successful Phase 3 clinical study involving 144 enrolled patients with advanced prostate cancer, demonstrating the drug's efficacy and safety. Remarkably, 97.9% of participants reached the primary endpoint, establishing CAMCEVI ETM as a robust treatment option.

Transition to Market

In anticipation of the commercial launch, Foresee expects the official rollout to occur post-receipt of a J-code, crucial for market access. The company has devised a strategic approach to navigate the commercial landscape, aiming to optimize both immediate uptake and long-term growth potential. CAMCEVI ETM will be available through Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, which holds exclusive commercialization rights.

Foresee Pharmaceuticals: A Commitment to Innovation

Headquartered in Taiwan and listed on the Taipei Exchange (TPEx 6576), Foresee Pharmaceuticals is dedicated to advancing healthcare through innovative therapies. The firm's research and development efforts center on two main arenas: the unique Stabilized Injectable Formulation (SIF) technology and pioneering clinical programs targeting rare, severe diseases with high unmet needs. The approval of CAMCEVI 42 mg, an earlier formulation for advanced prostate cancer, which launched in the U.S. in April 2022, showcases Foresee's ongoing commitment to pharmaceutical development.

Currently, the company is also pursuing regulatory approvals for the three-month formulation of CAMCEVI ETM in the EU while planning further clinical studies for indications such as central precocious puberty (CPP) and premenopausal breast cancer in collaboration with partners.

Looking Ahead

The future looks bright for Foresee Pharmaceuticals, with multiple programs in the pipeline aimed at addressing critical medical challenges. Innovations such as Aderamastat (FP-025), targeting inflammatory diseases, and Mirivadelgat (FP-045), an activator for pulmonary hypertension, illustrate the company's broad therapeutic ambitions.

In conclusion, the FDA's approval of CAMCEVI ETM not only signifies a victory for Foresee Pharmaceuticals but also provides hope for patients battling advanced prostate cancer, enhancing their treatment options and overall quality of life. As Foresee continues to build on this momentum, the biopharmaceutical industry will be watching closely for its next innovative breakthroughs.

For more information, visit Foresee Pharmaceuticals.