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
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
Lannett Company, Inc.
SIGA Technologies, Inc.
United Therapeutics Corporation
) look more attractive with a Zacks Rank #1 (Strong Buy).
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