Application for Partial Change to Egg White Labelling22 December 2011
JAPAN - Eisai Co. Ltd announced yesterday that its pharmaceutical manufacturing and marketing subsidiary Sannova Co. Ltd submitted an application for partial change to the approved label for egg white lysozyme preparation Neuzym to Japan's Ministry of Health, Labour and Welfare (MHLW).
The company is seeking approval to remove alveolar pyorrhea and other conditions as approved indications for the product as well as to make changes to dosage and administration.
The application submitted applies to all six products that make up the Neuzym Series - Neuzym Tablets (10 mg, 30 mg and 90 mg), Neuzym Granules (10 per cent), Neuzym Fine Granules (20 per cent), and Neuzym Syrup (0.5 per cent). While Sannova is the marketing and manufacturing authorization holder for Neuzym, Eisai is responsible for marketing the products.
Neuzym and other egg white lysozyme preparations have been designated by the MHLW Pharmaceutical Affairs and Food Sanitation Council's Special Committee on Drug Efficacy Reevaluation as drugs for which efficacy must be reevaluated. Given the actual utilization of Neuzym in the current healthcare environment, Eisai and Sannova are now in the process of developing the protocol for additional clinical studies to reevaluate the efficacy of the preparation.
However, the two companies have determined that it would not be feasible to conduct any further studies in the currently approved indications of "alveolar pyorrhea (inflammatory type)" and "hemorrhage during or after minor operations (dentistry and urology)", and have therefore submitted an application to remove these indications and make changes to dosage and administration for Neuzym accordingly.
While Neuzym will no longer be able to be used in the treatment of "alveolar pyorrhea (inflammatory type)" and "hemorrhage during or after minor operations (dentistry and urology)" following approval of the partial label change, Eisai and Sannova will work to ensure that information is provided to healthcare professionals in order to avoid confusion either in the medical setting or amongst patients being treated with the preparation.