FDA asks for more data on Emend injection

US drug major Merck & Co has received an "approvable" letter from the Food and Drug Administration for the New Drug Application for its drug Emend (fosaprepitant dimeglumine) for injection, also known as MK-0517, an investigational intravenous therapy for chemotherapy-induced nausea and vomiting (CINV).

The FDA informed Merck in the letter that, before clearance can be issued, additional manufacturing validation and stability data are required as well as certain other data. Merck is working to provide the information requested and plans to submit this within the next few months. Once a response to the letter has been submitted, the agency's decision is expected in approximately six months, in accordance with FDA policy. Despite this delay, on the day of the news, May 11, shares in the firm rose 1.8% to $52.

Merck stressed that the application for Emend for injection and receipt of the "approvable" letter does not relate in any way to the manufacturing and availability of the oral formulation of the drug, which utilizes a different manufacturing process and remains available for patient use.