Amgen has filed its eagerly-anticipated investigational osteoporosis treatment denosumab with US regulators.
Specifically, the firm has submitted a Biologics License Application with the US Food and Drug Administration for denosumab, a human monoclonal antibody that targets RANK ligand. The application is for the treatment and prevention of postmenopausal osteoporosis, plus bone loss in patients undergoing hormone ablation for either prostate or breast cancer.
Amgen said that the BLA submission contains data from six Phase III trials involving more than 11,000 patients and Roger Perlmutter, executive vice president of R&D, noted that all of the studies showed denosumab’s ability to increase bone mineral density at all skeletal sites measured. He added that two of the Phase III studies with fracture endpoints, in the PMO and prostate cancer settings, demonstrated the drug’s ability to reduce fracture.
Amgen also intends to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for use of denosumab in these indications. The company believes that the drug has the potential to be a blockbuster.
FDA wants to see REMS on psoriasis drug
Staying with new biologics, the FDA has told Johnson & Johnson unit Centocor that it requires additional information before it can make a final decision on ustekinumab for psoriasis.
In a complete response letter, the agency has asked for a “risk evaluation and mitigation strategy” to ensure that the benefits of ustekinumab outweigh the risks. The REMS must contain a medication guide and communication plan.
However J&J noted that the FDA did not request any additional studies and Jerome Boscia, Centocor’s senior vice president for clinical R&D said that the firm will respond to the agency in January. “We are confident that we can expeditiously address the questions set forth in the complete response letter,” he added, and that approval is very achievable.
In June, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended the human monoclonal antibody which targets the cytokines interleukin-12 and 23, naturally occurring proteins that are believed to play a role in inflammatory disorders, including psoriasis. Last month, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for ustekinumab.
