Amgen applies for FDA approval of denosumab osteoporosis, cancer treatment
THOUSAND OAKS, Calif. Amgen has submitted an approval application to the Food and Drug Administration for denosumab, a treatment for women with postmenopausal osteoporosis and patients undergoing hormone ablation for prostate and breast cancer, the biotech company announced Friday.
The approval application contains data from six phase 3 trials involving more than 11,000 patients, the company said. Amgen also plans to submit applications in Canada, Australia, the European Union and Switzerland.
“Today’s submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies,” Amgen EVP for research and development Roger Perlmutter said.
Biosimilars could save significant amounts in healthcare costs, report concludes
ARLINGTON, Va. A report by the Congressional Budget Office on the potential savings that biosimilars could create has drawn a response from the Generic Pharmaceutical Association.
“As Congress grapples with both the economic and healthcare crises facing our nation, the CBO Budget Options Report is concrete evidence that bringing safe, effective and affordable biogenerics to patients can result in significant healthcare cost savings for the federal government,” GPhA president and chief executive officer Kathleen Jaeger said in a statement.
“Specifically, the CBO Budget Options Report states that establishing a pathway for the approval of biogenerics will result in a multi-billion dollar savings potential for the federal government.”
Currently, the law does not permit the Food and Drug Administration to approve biosimilars, sometimes called biogenerics.
FDA approves Genzyme drug to support bone marrow transplant recovery
ROCKVILLE, Md. The Food and Drug Administration has approved a drug by Genzyme that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer, according to an FDA statement Thursday.
Mozobil (plerixafor) is for use with the growth factor granulocyte-colony stimulating factor for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas.
Before receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis, in which blood stem cells are collected and stored for infusion after therapy.
Patients receive G-CSF to help release and collect stem cells from the bone marrow. When used with G-CSF, Mozobil boosts the number of stem cells released from the bone marrow into the blood stream.
“Collecting the millions of cells needed for a bone marrow transplant can take hours or days,” director of the FDA Center for Drug Evaluation and Research’s Office of Oncology Drug Products Richard Pazdur said in a statement. “Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy.”