AbbVie is pleased that the Japanese MHLW
has granted priority review for our interferon and ribavirin-free, 12-week, two direct-acting antiviral treatment regimen.
To reduce costs, the MHLW
has enforced many cost-containment measures, such as reimbursement cuts, increased co-payments and so on.
This is of concern to MHLW
, especially since the incidence of diabetes continues to increase in Japan.
The average calcium intake across all age groups has been relatively constant for the past 30 years in Japan, ranging between 531 mg and 585 mg of calcium per day, despite the MHLW
efforts to encourage increased calcium consumption.
The link between obesity and diabetes and other health conditions is well known, however, and it is clear that the MHLW
is now encouraging the connection.
In addition, MHLW
coverage of fractional flow reserve (FFR) guidewires was recently expanded to include use in diagnostic procedures, and this offers a huge growth opportunity.
Although direct diabetes prevention and treatment claims in Japan would be considered drug claims and therefore not allowed for foods, the MHLW
is continuing to support the FOSHU products that claim to be able to reduce or control blood sugar levels.
As a next step, AMS will seek to obtain national reimbursement through the MHLW
The submission to the MHLW
is based on the results of three global clinical trials within the pivotal EINSTEIN Clinical Trial Programme, and is supported by the J-EINSTEIN studies (J-EINSTEIN DVT and J-EINSTEIN PE), which were run entirely in Japan.
Zeria had submitted the application for marketing approval to the MHLW
in Japan in Sep 2010.
The annual National Nutrition Survey in Japan, also published by MHLW
, is an excellent source of current and historical data related both directly and indirectly to cardiovascular health.
The company anticipates that in October the MHLW
will review that all necessary regulatory steps have been addressed before the application is taken to the Minister's Office for signature.