FDA Grants Priority Review Designation to Denosumab BLA
The US Food and Drug Administration has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor manufactured by Amgen (Thousand Oaks, CA), for the treatment of bone metastases to reduce skeletal-related events (SREs) in patients with cancer.
The US Food and Drug Administration has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor manufactured by Amgen (Thousand Oaks, CA), for the treatment of bone metastases to reduce skeletal-related events (SREs) in patients with cancer. Filed in mid-May with the FDA, the biologics license application (BLA) submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies.
Priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Consistent with priority review guidelines, the FDA will target an agency action within six months of the application submission date, resulting in a Prescription Drug User Fee Act (PDUFA) action date of November 18.
Denosumab is the first fully human monoclonal antibody in late-stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-related bone diseases.
Amgen also has submitted marketing applications in the European Union, Australia, Canada, and Switzerland. In Japan, Amgen is working with its licensing partner, Daiichi-Sankyo Limited and a submission is planned in the near future.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Novel Modalities Spur Shift in Outsourcing Processes and Partnerships
May 8th 2025While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as transactional relationships, but true partners with a common goal of getting drugs to patients faster.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
