EISAI submits Application for reevaluation of efficacy and partial change to label egg white lysozyme
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its pharmaceutical manufacturing and marketing subsidiary Sannova Co., Ltd. (Headquarters: Gunma Prefecture, President: Toru Takekawa, “Sannova”) has submitted an application for reevaluation of the indication of bronchitis, bronchial asthma and bronchiectasis for egg white lysozyme preparation Neuzym® (lysozyme hydrochloride, “lysozyme”). At the same time, Sannova has also submitted an application for a partial label change to remove chronic sinusitis as an approved indication for Neuzym. The Neuzym series consists of six products -Neuzym Tablets (10 mg, 30 mg, 90 mg), Neuzym Granules (10%), Neuzym Fine Granules (20%) and Neuzym Syrup (0.5%). While Sannova is the manufacturing and marketing authorization holder of Neuzym, Eisai is responsible for marketing the products.
After receiving a designation to reevaluate lysozyme preparations including Neuzym in January 2012, Eisai, Sannova and three other companies*1 handling lysozyme have been jointly carrying out post-marketing clinical studies (double blind, placebo-controlled comparative studies) to verify efficacy of these drugs for chronic sinusitis, bronchitis, bronchial asthma, and bronchiectasis.
Among the studies on the lower respiratory tract diseases bronchitis, bronchial asthma and bronchiectasis, the clinical pharmacology study on chronic obstructive pulmonary disease (COPD)*2 and asthma with sputum symptom (Study LYS-003) suggested that lysozyme has efficacy as an add-on to standard treatment in patients with COPD. In the study to assess the efficacy of lysozyme as an add-on to standard treatment in preventing exacerbation in patients with COPD (Study LYS-002), a statistically significant improvement over placebo in the study’s primary endpoint could not be verified. However, in the study’s secondary endpoints, lysozyme showed a trend of greater improvement over placebo across the treatment period. The results from both studies suggested that lysozyme has efficacy in improving difficulty of expectoration compared to placebo. Since there are also many cases of hypersecretion and difficulty expectorating in lower respiratory tract diseases such as COPD, it is believed that lysozyme, which eases the ejection of sputum, makes a significant clinical difference, and therefore an application has been submitted for reevaluation of the indication of bronchitis, bronchial asthma and bronchiectasis.
Meanwhile, in the study on chronic sinusitis (Study LYS-001), the efficacy of lysozyme as an add-on to the current standard treatment of clarithromycin could not be verified and an application for a partial label change has been submitted to remove the indication of chronic sinusitis for Neuzym. With the approval of the partial label change, Neuzym will no longer able to be used for the indication of “chronic sinusitis.” Eisai and Sannova will strive to ensure that information is provided to healthcare professionals in order to avoid confusion either in the medical setting or amongst patients taking Neuzym.