) 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
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
) 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
) are better positioned carrying a Zacks Rank #2 (Buy).
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