FDA panel to review resubmitted NDA for pixantrone
SEATTLE — The Food and Drug Administration’s Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.
The company said that the panel will review the NDA for pixantrone, which is designed to treat relapsed or refractory aggressive non-Hodgkin’s lymphoma in patients who failed two or more lines of prior therapy.
"We are pleased the FDA Office of Oncology Drug Products chose to bring our pixantrone NDA back to ODAC for review now that we have provided additional information and data recommended by the Office of New Drugs that we believe addresses the issues raised in the OODP complete response letter of April 2010," Cell Therapeutics CEO James Bianco said. "We believe the NDA demonstrates that pixantrone has a favorable benefit risk profile compared to standard chemotherapy in patients with relapsed or refractory aggressive NHL, a patient population for which there are no approved agents."
Cell Therapeutics noted that while the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the agency itself.
FDA approves Prevnar 13 in older adults
NEW YORK — The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.
Pfizer announced the FDA approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) as a single-dose for adults.
"Pneumococcal disease, including pneumonia, in adults 50 years and older represents a significant personal and social health burden in the United States," Pfizer chairman and CEO Ian Read said. "The FDA approval of Prevnar 13 for these adults offers the potential to contribute to the health of millions of aging Americans."
FDA approves Mylan epilepsy drug
PITTSBURGH — The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.
The FDA approved Mylan’s levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.
The drug is a generic version of UCB’s Keppra XR, used to treat partial onset seizures in epilepsy patients ages 16 years and older.
Various versions of the drug had sales of about $162.8 million during the 12-month period ended in September, according to IMS Health.