TAIPEI, Oct. 9, 2020 /PRNewswire/ -- Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee") announced today that the 505(b)(2) New Drug Application (NDA) for FP-001 LMIS 50mg, or CAMCEVI™ 42MG, a ready-to-use 6-month depot formulation of leuprolide mesylate, has been accepted for review by the U.S. Food and Drug Administration (FDA).
In its Day-74 letter, the FDA stated that the New Drug Application (NDA) for CAMCEVI 42MG is sufficiently complete to permit a substantive review. The goal date under the Prescription Drug User Fee Act (PDUFA) is May 27, 2021.
"This marks another important regulatory milestone for the CAMCEVI franchise," said Dr. Ben Chien, Founder and Chairman of Foresee. "We are confident that if approved, with a strong commercial partnership in the US, CAMCEVI 42MG and the CAMCEVI franchise will provide patients, as well as healthcare providers, a safe and easy-to-use treatment option with its differentiated ready-to-use profile. We look forward to the successful launch of the CAMCEVI franchise."
The NDA submission for CAMCEVI 42MG is supported by a previously communicated successful Phase 3 clinical study in 137 Advanced Prostate Carcinoma patients, where treatment with CAMCEVI 42MG injection every 6 months was demonstrated to be effective, safe and well tolerated.
About Foresee Pharmaceuticals Co., Ltd.
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange. Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, secondly its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs.
Foresee's product portfolio includes late stage and early stage programs such as FP-001, 6-month and 3-month, stable, ready-to-use versions of leuprolide mesylate for injection, for which regulatory approval reviews are currently underway in US and EU for the 6-month product and regulatory submissions for 3-month product are in preparation; FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in a Phase 2 proof-of-concept study, and target to initiate Phase 2 study for COVID-19 virus induced acute respiratory distress syndrome (ARDS); FP-045, a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia Disease, and FP-004, a novel, subcutaneously injectable product in development for the treatment of opioid use disorder and pain.
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