Healthcare Sector Review: Orexigen Reaches Agreement with FDA, Amgen’s Xgeva

Orexigen Therapeutics (NASDAQ:OREX) announced that it has reached agreement with the U.S. FDA on a Special Protocol Assessment, or SPA, for the Contrave outcomes trial. On Jan. 31, the company received a Complete Response Letter to its New Drug Application, or NDA, noting a single approval deficiency related to cardiovascular safety, requiring Orexigen to conduct a randomized, double-blind, placebo-controlled cardiovascular outcomes trial prior to approval. The objective of the trial is to demonstrate that Contrave does not unacceptably increase the risk of major adverse cardiovascular events, or MACE. The company plans to initiate the Contrave outcomes trial late in Q2 of 2012.

The shares closed at $3.21, up $0.45, or 16.3%, on the day. Its market capitalization is $154.35 million.

Amgen, Inc. (NASDAQ:AMGN): In a briefing document posted in advance of a Food and Drug Administration advisory committee meeting regarding Amgen’s Xgeva, denosumab, the FDA said study 20050147 met its pre-specified primary objective, but “it is unclear whether an improvement in BMFS alone in patients with CRPC at high risk for bone metastases is an adequate measure of clinical benefit in support of new labeling claims for a new patient population.” The document adds that it is unclear whether the magnitude of the BMFS improvement in the study is clinically meaningful. Amgen submitted its efficacy supplement to the Biologics License Application for Xgeva to support the proposed indication Xgeva is indicated for the treatment of men with castrate-resistant prostate cancer at high risk of developing bone metastases. Xgeva prolongs bone metastasis-free survival by reducing the risk of developing bone metastases.

The shares closed at $69.12, down $0.16, or 0.23%, on the day. Its market capitalization is $55.02 billion.

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