IDM Pharma Announces Plans to Amend New Drug Application for Mifamurtide

IDM Pharma announced that it intends to take immediate action to supplement the data in its current new drug application (NDA) for L-MTP-PE, formerly known as Junovan, which is being reviewed for the treatment of children and adolescents with nonmetastatic osteosarcoma.

IDM said it plans to collect and submit additional Phase III data that will support the benefit of L-MTP-PE (mifamurtide) in the treatment of non-metastatic osteosarcoma.

When the additional follow up data have been collected, the company said it expects to submit an amendment to the NDA to the FDA by the first quarter of 2008.

In clinical trials, treatment with L-MTP-PE was generally well-tolerated, and adverse events were mild-to-moderate and included chills, fever, nausea, vomiting, myalgia, headache, tachycardia (fast heart rate), hypo- and hypertension, fatigue and shortness of breath.