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Japanese Approval for Bayer's drug

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Bayer’s (BAYRY - Free Report) HealthCare segment recently received encouraging news as the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Stivarga (regorafenib). Stivarga is approved in Japan for the treatment of patients suffering from unresectable, advanced/recurrent colorectal cancer (CRC).

Bayer stated in its press release that CRC is the third most common cause of cancer death in Japan. More than 40,000 people die in Japan every year due to CRC.

The Japanese approval of Stivarga was based on results from the phase III CORRECT study. Results from the study showed improvement in overall survival and progression-free survival in comparison to placebo, in patients suffering from metastatic CRC (mCRC) and whose disease had progressed after approved standard therapies.

Stivarga is already approved in the US for treating patients suffering from mCRC, whose disease had progressed even after treatment with standard drugs prescribed for the disease. Stivarga is also approved for metastatic gastrointestinal stromal tumors (GIST) indication in the US. Bayer is also seeking EU approval of Stivarga for the treatment of mCRC.

Bayer, meanwhile, received a huge setback earlier this month when the company and its partner Johnson & Johnson (JNJ - Free Report) received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) for their supplemental New Drug Application (sNDA) for Xarelto (2.5 mg twice daily) for the reduction of the risk of secondary cardiovascular events in patients suffering from ACS.

The second CRL for Xarelto is a big disappointment for the company. Bayer, a large cap pharma company, currently carries a Zacks Rank #4 (Sell). Meanwhile, other large cap pharma stocks such as Novo Nordisk (NVO - Free Report) and AbbVie Inc. (ABBV - Free Report) are better positioned carrying a Zacks Rank #2 (Buy).

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