Merck will respond "within the next few months" to FDA's May 3 "approvable" letter for its Emend IV (fosaprepitant dimeglumine) injection for the prevention of chemotherapy-induced nausea and vomiting, the firm told "The Pink Sheet" DAILY.

FDA is asking Merck to provide additional manufacturing validation and stability data as well as "certain additional data," which the company declined to specify, before the agency can issue approval.

The firm expects FDA review would be completed within six months after Merck submits a complete response.

"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 Emend , which utilizes a completely different manufacturing process," Merck said in a May 14 news release.

The oral capsule form of Emend (aprepitant) was approved in March 2003 as a new molecular entity. It is indicated, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin.

FDA approved an additional claim for prevention of postoperative nausea and vomiting in June 2006 (¹ Also see "Merck Anti-Emetic Emend Adds Postoperative Nausea Indication" - Pink Sheet, 11 July, 2006.).

Emend was approved as the first-in-class substance P/neurokinin-1 receptor antagonist. The predominant antiemetic class is the 5-HT3 antagonists, which includes MGI Pharma's Aloxi (palonsetron), Roche's Kytril (granisetron), ondansetron (GlaxoSmithKline's Zofran and generics) and Sanofi-Aventis' Anzemet .

- Pamela Taulbee (p.taulbee@elsevier.com)

FDA “Approvable” Letter Requests Validation, Stability Data For Merck’s Emend IV

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