FDA denies approval for AMAG’s Feraheme
LEXINGTON, Mass. The Food and Drug Administration has delivered a complete response letter to AMAG Pharmaceuticals for a drug for treating anemia in kidney disease patients, AMAG announced Monday.
The FDA said it will not approve the drug Feraheme (ferumoxytol) until it receives data to clarify a specific chemistry, manufacturing and controls issue; resolution of deficiencies observed during the pre-approval inspection of AMAG?s factory; and finalization of labeling discussions with the FDA.
“We will continue to work expeditiously and collaboratively with the FDA to address the issues raised in the complete response letter,” AMAG president and CEO Brian Pereira said. “We are pleased with the progress that we have made in addressing the observations raised during the pre-approval inspection of our manufacturing facility, and we are fully committed to conducting our manufacturing operations consistent with the highest quality standards.”
AMAG originally submitted its approval application for Feraheme in December 2007 and received a complete response letter in October of this year.
AstraZeneca seeks approval for use of Nexium in infants
NEW YORK AstraZeneca has submitted a supplemental application to the Food and Drug Administration for the use of the drug Nexium as a short-term treatment of gastroesophageal reflux disease in infants.
GERD, which is closely related to acid-reflux disease, affects about 7 million children in the United States.
The FDA has already approved Nexium (esomeprazole magnesium) for use in children between 1 and 17 years of age, though AstraZeneca hopes to have it approved in infants less than a year old.
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.