FDA Accepts The Medicines Company's Filing For NDA For Oritavancin

The Medicines Company announced in a press release that the Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for oritavancin. The intravenous antibiotic for investigational use was granted priority review. Oritavancin is indicated for acute bacterial skin and skin structure infections (ABSSSI). Matthew Wikler, MD, Vice President and Medical Director, Infectious Disease Care for The Medicines Company said, "We look forward to working with the FDA during the review process, and sharing the knowledge we have gained in our studies of oritavancin."  

Acute Bacterial Skin and Skin Structure Infections  

ABSSSI is a condition where bacteria infects the skin. Uncomplicated infections include lesions, furuncles, abscesses, and cellulitis. Complicated infections include burns, ulcers, and serious abscesses. Infections at certain sites like the rectal area may be classified as complicated due to the risk of other pathogens. Treatments include antibiotics and surgery.

Oritavancin

Oritavancin is an analogue of vancomycin, manufactured in a semi-synthetic preparation. The FDA designated oritavancin as a Qualified Infectious Disease Product (QIDP). QIDP status gives the The Medicines Company five years of exclusivity upon approval. The FDA also gave the drug priority review, meaning it will make a decision within six months instead of the standard ten months. The FDA stated that the Prescription Drug User Fee Act (PDUFA) date for action on the NDA is August 6, 2014.

The Medicines Company based its NDA on two Phase III clinical trials, SOLO I and SOLO II. These clinical trials, under a Special Protocol Assessment (SPA) agreement with the FDA, studied safety and effectiveness. Participants took a single dose (1200 mg) of oritavancin. The control group took seven to ten days of vancomycin, twice daily. About 2,000 people took part in the trials. Side effects of the drug included headache, nausea, vomiting, and diarrhea.

About The Medicines Company

The Medicines Company's headquarters are in Parsippany, NJ. The company began in 1996 and employs about 500 people. It has operational centers in Europe, Asia, and the Middle East. The firm focuses on hospital and acute care treatments. Products in the U.S. approved for marketing include Angiomax (bivalirudin), Cleviprex (clevidipine), and Argatroban. Pipeline agents include cangrelor, oritavancin, MDCO-157, MDCO-2010, and MDCO-216.

Source:

http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol-newsArticle&ID=1901078&highlight