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Label Expansion for Astellas

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Astellas Pharmaceuticals Inc. and Kyowa Hakko Kirin Co., Ltd. recently announced the receipt of Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for the drugs, Pasetocin and Sawacillin, for an additional indication.

The additional indication is helicobacter pylori (H. pylori) eradication by triple therapy with proton pump inhibitors and either clarithromycin or metronidazole.

We note that Astellas is also seeking label expansion for Dormicum in Japan. The company has submitted an additional indication application for “conscious sedation in dentistry and dental surgery”. Earlier, this drug was approved for three indications, namely, anesthetic premedication, introduction and maintenance of general anesthesia and sedation during artificial respiration in critical care.

A few days back, Astellas had announced final overall survival (OS) results from the phase III TIVO-1 study on tivozanib. The TIVO-1 (TIvozanib Versus sOrafenib in 1st line advanced RCC) study was conducted in patients suffering from advanced renal cell carcinoma (RCC). The company is currently seeking US Food and Drug Administration (FDA) approval for tivozanib. A New Drug Application (NDA) was submitted in Sep 2012. The FDA accepted the application in Nov 2012 with a response expected by Jul 28, 2013.

Meanwhile, Astellas is looking to expand Tarceva’s label as well. In Jan 2013, the US FDA accepted Astellas’ supplemental new drug application (sNDA) for Tarceva. Astellas is looking to expand the label of Tarceva for first-line use in patients suffering from locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations. The FDA will review the application on a priority basis, with a response likely to be out in the second quarter of 2013. Tarceva is currently approved and marketed for maintenance therapy and second- or third-line therapy in advanced non-small cell lung cancer (NSCLC).

Astellas carries a Zacks Rank #4 (Sell). Currently, companies like Lannett Company, Inc. (LCI - Free Report) , SIGA Technologies, Inc. and United Therapeutics Corporation (UTHR - Free Report) look more attractive with a Zacks Rank #1 (Strong Buy).

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