Forest expects to file ceftaroline application by end of 2009
Posted on 24/06/2009 in Pharmaceutical Company Product News
Forest expects the new drug application for ceftaroline to be filed towards the end of the year.
The company recently disclosed data from two global multi-centre phase III studies of the treatment which is intended to manage community-acquired bacterial pneumonia.
As well as achieving high cure rates in patients with moderate to severe levels of the disease, the medication also met the primary objective of non-inferiority.
Dr Dirk Thye is president of the anti-infective subsidiary of Forest called Cerexa.
He said the positive results would serve as the basis of the new drug application.
"We are extremely pleased with the results emanating from both phase III ? studies," Dr Thye remarked.
"These results represent a significant development milestone for ceftaroline."
Last month Forest and Ironwood Pharmaceuticals announced data from a study that assessed the safety and efficacy of linaclotide in patients with irritable bowel syndrome with constipation.
The novel, first-in-class agent was found to improve symptoms of the medical condition.
