Merck's EpiPen gets Japanese marketing approval
Merck Ltd, the Japanese subsidiary of Merck KgaA, of Germany, has received approval to market EpiPen injection 0,3mg, from Japan's Ministry of Health, Labour and Welfare (MHLW).
Merck Ltd, the Japanese subsidiary of Merck KgaA, of Germany, has received approval to market EpiPen injection 0,3mg, from Japan's Ministry of Health, Labour and Welfare (MHLW).
The marketing approval is specifically restricted on the treatment of anaphylaxis in response to insect stings.
Merck expects to launch EpiPen, which needs a doctor's prescription but is not reimbursed by the Japanese health insurance system, within the next few weeks. The company will also work closely with regulatory authorities in Japan to expand the existing marketing authorisation to include treatment of anaphylaxis triggered by food, drug, or other types of allergies.
EpiPen is used by the patient in life-threatening situations when medical support is not immediately available. The autoinjector administers intramuscularly a single 0.3mg dose of epinephrine. In Japan, about 30 deaths occur annually from anaphylaxis due to insect stings.
'With this approval, Merck KGaA, mainly known in Japan as a manufacturer of high-end speciality chemicals for the automotive, semiconductor and electronic industries, enters the stage of Ethical Pharmaceutical business in the world's second-largest pharmaceutical market,' said Klaus Diehl, president of Merck Japan.