Monday, February 27, 2012

Bydureon and three other drugs receives approval recommendation in Japan

Four New drug Approval Recommendations in Japan
Bydureon (Amylin ) - Type 2 Diabetes
Bydureon (GLP-1 receptor agonist)  has been recommended for approval of type 2 diabetes. Bydureon contains the same active ingredient as Byetta (exenatide), which is already marketed and is administered twice daily.  Bydureon  has  to be administered once a week. The re-examination period is until October 26, 2018. 

Kiklin Capsule (Astellas) - Hyperphosphatemia
Kiklin Capsule 250 mg (bixalomer) has also been recommended approval for the improvement of hyperphosphatemia in chronic kidney failure patients on dialysis.  Kiklin is an amine-functional polymer that is not absorbed by the gastrointestinal tract, it absorbs the phosphorus in food that is consumed and thus controls increases in blood phosphorus levels 

Apomorhine hydrochloride (Kyowa Hakko Kirin) - Parkinson Disease
Apomorphine is a NME but similar to dopamine, and acts as an agonist by binding to dopamine D1/D2 receptors present on the surface of nerve cells in the brain. It will be indicated for the improvement of off-symptoms in Parkinson’s disease (when other treatments for Parkinson’s disease are not adequately effective).  The re-examination period is 10 years. As of June 2011.

Additional Administration route for Minrin - Melt OD tablets (Ferring Pharmaceuticals) - Nocturnal enuresis
Minirin was recommended approval for use as Melt OD Tablet 120 µg and 240 µg (desmopressin acetate hydrate). Minrin is an antidiuretic hormone drug that helps improve decreased urine concentration functions by promoting the reabsorption of water.


  1. why isn't this article posted on the amln web site???

    1. Generally positive approval recommendations received from Japanese regulators are not published by the company on their website