生物谷报道:由 Genentech, Biogen Idec 和 Roche 三家制药公司合作生产美罗华(Rituxan),一种治疗非何杰金氏淋巴瘤的新药,经前期试验表明,美罗华对大明何杰金氏淋巴瘤有良好的效果,因此这三家公司已联合向FDA 递交申请,希望能够扩大其适用人群。该药原来仅适用于早期病人。这些公司希望美罗华的标签上能够标注上:(与其他化疗制剂联合使用)治疗这一疾病的主要用药。
另外,该药还用于治疗关节炎等其它病症。这一申请提交FDA后,三家公司的股票应声上涨。
Biotech companies Genentech Inc. and Biogen Idec Inc. and Swiss drug maker Roche said Wednesday that they filed a supplemental application with the Food and Drug Administration to expand the label for Rituxan to treat a larger population of people with non-Hodgkins lymphoma, a cancer of organs that make up the immune system.
The companies said they have requested a priority review from the FDA. If granted, the agency would decide on the supplemental application within six months rather than the standard 10 months.
Rituxan is currently approved as a treatment for low-grade non-Hodgkins lymphoma patients who have failed other therapies or who have relapsed. The supplemental application seeks to expand Rituxan's labeling to be used as a front-line, or first, treatment used in combination with other chemotherapy regimens for patients with intermediate or aggressive forms of the disease.
The application included clinical data from 1,854 previously untreated patients and used overall survival as a primary endpoint.
The companies are also studying Rituxan as a treatment for rheumatoid arthritis, a condition when the immune system inappropriately attacks joint tissue, causing inflammation and destroying cartilage, tendons and bones, often resulting in disability.
Genentech shares fell 53 cents to $88.43 in morning trading on the New York Stock Exchange, while Biogen shares fell 31 cents to $40.77 on the Nasdaq.