FDA Accepts Camurus' NDA for Oclaiz™ (CAM2029) in Acromegaly Treatment
核心洞察
The FDA has accepted Camurus (搜索)' New Drug Application (NDA) for Oclaiz™ (CAM2029) for treating acromegaly (搜索), setting a PDUFA target action date of October 21, 2024.
Oclaiz™ is a novel, once-monthly subcutaneous depot formulation of octreotide designed for convenient self-administration and enhanced drug exposure.
The NDA is supported by data from seven clinical studies, including two Phase 3 trials within the ACROINNOVA program, demonstrating superior biochemical control compared to placebo.
The U.S. Food and Drug Administration (FDA) has accepted for review Camurus (搜索)' New Drug Application (NDA) for Oclaiz™ (CAM2029) for the treatment of patients with acromegaly (搜索). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 21, 2024.
Oclaiz™ (CAM2029) is an investigational, ready-to-use octreotide subcutaneous depot designed for convenient, once-monthly self-administration, enhanced octreotide plasma exposure, and robust disease control. Acromegaly (搜索) is a rare, slowly progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (搜索) (IGF-1) levels. The prevalence of acromegaly is estimated to about 60 cases per million.
Clinical Data Supporting Oclaiz™
The NDA for Oclaiz™ is based on data from seven clinical studies, including two Phase 3 studies within the ACROINNOVA program. These studies evaluated the efficacy and safety of CAM2029 in patients with acromegaly (搜索). CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide. In the Phase 3 ACROINNOVA program, CAM2029 showed superior biochemical control compared to placebo as well as improvements in symptom control, treatment satisfaction, and quality of life compared to standard of care with first-generation somatostatin receptor ligands (SRLs). The safety profile of CAM2029 was similar to that of approved injectable octreotide and lanreotide products with no new or unexpected findings.
Camurus' Perspective
"FDA’s acceptance of the NDA submission for Oclaiz™ marks a milestone in our efforts to develop a new, effective treatment for patients with acromegaly (搜索) with the potential for reduced treatment burden and increased quality of life," said Fredrik Tiberg, President & CEO, Camurus (搜索). "We are looking forward to working with the Agency during the registration process."
About Acromegaly
Acromegaly (搜索) leads to abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating and paresthesia. Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.