Merrimack Pharma Says FDA Grants Priority Review For MM-398 NDA

(RTTNews) - Merrimack Pharmaceuticals, Inc. (MACK) and Baxalta Inc., a wholly-owned subsidiary of Baxter International Inc (BAX), jointly announced that the New Drug Application for MM-398 (irinotecan liposome injection), also known as "nal-IRI," has been accepted for review by the U.S. Food and Drug Administration.

Merrimack is seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

In addition, the FDA has classified the NDA as having Priority Review status. A Priority Review designation is for drugs that treat serious conditions and, if approved, would provide significant improvements in the safety or effectiveness of the treatment of serious conditions compared to available therapies.

The FDA has set a goal of October 24, to take action under the Prescription Drug User Fee Act.