IRI: First-quarter jump in consumer confidence holding firm over the second quarter
Imbruvica gets expanded approval from FDA
SILVER SPRING, Md. — The Food and Drug Administration on Monday expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17, which is associated with poor responses to the standard treatment for CLL, according to the agency. The drug received breakthrough therapy designation for this use.
The agency is also approving new labeling to reflect the drug's clinical benefit in treating CLL, which is a rare blood and bone marrow disease that typically gets worse slowly over time. This causes a gradual increase in white blood cells called B lymphocytes.
“We continue to see advances in the availability of therapies to treat chronic lymphocytic leukemia, especially for difficult-to-treat patient populations,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Imbruvica is the fourth drug approved to treat CLL that received a breakthrough therapy designation, reflecting the promise of the breakthrough therapy designation program and demonstrating the FDA’s commitment to working cooperatively with companies to expedite the development, review and approval of these important new drugs.”
Imbruvica is co-marketed by Pharmacyclics and Janssen Biotech.
Sandoz takes step toward first U.S. generic biosimilar with FDA filing
HOLZKIRCHEN, Germany — The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced.
If approved, this would be the first biosimilar generic in the United States since the passage of the Biologics Price Competition and Innovation Act, which cuts down the approval process for potential biosimilar generics.
The application is to create a generic version of the biosimilar drug filgrastim, which is used to treat neutropenia, a condition that typically accompanies cancer or bone marrow diseases that causes a low white blood cell count. Amgen currently sells filgrastim as Neupogen.
“This filing acceptance represents a significant step toward making high-quality biologics more accessible in the U.S.,” Sandoz’s head of global biopharmaceutical and oncology injectable, Mark McCamish, said . “As they’ve done in Europe and other highly-regulated markets around the world, biosimilars are poised to increase US patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system.”
Sandoz currently sells its version of filgrastim as Zarzio in 40 other countries.