Marketing Approval for "KIPRES" Oral Granules 4mg
July 31, 2007
KYORIN Pharmaceutical Co., Ltd. (Headquarter: Tokyo, President: Ikuo Ogihara), a subsidiary of KYORIN Co., Ltd. announced today that the Ministry of Health, Labour and Welfare approved "Kipres® Oral Granules 4mg" (INN: montelukast sodium), leukotriene receptor antagonist / bronchial asthma treatment drug, on July 31, 2007.
Montelukast sodium was developed by Merck & Co., Inc., Whitehouse Station, N.J.,U.S.A as the long-term control drug for bronchial asthma, and KYORIN Pharmaceutical has been marketing products containing the agent, "Kipres® Tablets 10" for adults and "Kipres® Chewable Tablets 5" for children aged 6 years and older, since August 2001.
In recent years, the morbidity rate of pediatric asthma has been increasing, and it is said that about 90% of pediatric asthma starts by 5 years of age under the trend that the age of onset is lowering. Since the drugs not only having wider safety window as well as efficacy, but also designed with consideration of drug-compliance such as easy-to-dose to infant patients by their parents are desired, KYORIN Pharmaceutical has been working on developing the formulation for infants under 6 years of age.
"Kipres® Oral Granules 4mg" is for patients aged 1 years and older but under 6 years, and has already been approved as "montelukast sodium oral granules" (for under 6 years of age) in 62 countries around the world. The domestic clinical trials with this formulation demonstrated the decrease in number of minor attacks in the infant asthma and high tolerability. This formulation is orally taken one pack each once daily before bedtime and can be taken without water since it is easily soluble in the mouth without tasting bitter.
The leukotriene receptor antagonist including Kipres® is recommended by New Japanese Pediatric Guideline for the Treatment and Management of Asthma 2005 as the long-term control drug of pediatric asthma in any severity (Steps 1 through 4). We expect that "Kipres® Oral Granules 4mg", which has good efficacy, provides a new choice of treatment for the phase of infant during which incidence of bronchial asthma onset concentrates.
We will make efforts to have this new formulation immediately penetrate into the market and aim to establish a consolidated foundation of Kipres® franchise.
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