Regeneron Gains As New Data Favors Higher Dose Of Flagship Eye Disease Drug
Regeneron Gains As New Data Favors Higher Dose Of Flagship Eye Disease Drug
新数据支持更高剂量的眼科旗舰药物，Regeneron收益
- Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) two pivotal trials evaluating aflibercept 8 mg with 12- and 16-week dosing regimens met the primary endpoints in diabetic macular edema (DME) and wet age-related macular degeneration (wAMD).
- The PHOTON trial in DME and the PULSAR trial in wAMD achieved non-inferiority in vision gains compared to the currently-approved 2 mg Eylea 8-week dosing regimen.
- Also Read: Regeneron's Price Target Cut On Dim Prospects For Its Flagship Eye Product.
- 91% and 89% of DME patients were rapidly initiated and maintained on 12- and 16-week dosing intervals (without the need for regimen modification) through week 48, respectively.
- 79% and 77% of wAMD patients were rapidly initiated and maintained on 12- and 16-week dosing intervals.
- The safety of aflibercept 8 mg was similar to Eylea and consistent with the well-established safety profile of Eylea from previous clinical trials.
- Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG (OTC:BAYRY). In the U.S., Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of Eylea.
- Price Action: REGN shares traded higher by 13.30% at $675.77 on the last check Thursday.
- Regeneron制药公司的纳斯达克代码：REGN)两项评估afLibercept 8毫克、12周和16周给药方案的关键试验达到了治疗糖尿病黄斑水肿和湿性年龄相关性黄斑变性的主要终点。
- 与目前批准的2 mg Eylea 8周给药方案相比，在DME进行的光子试验和在wAMD进行的脉冲星试验在视力改善方面取得了不逊色的效果。
- 另请阅读： Regeneron下调其旗舰眼科产品前景黯淡的目标价格.
- 分别有91%和89%的DME患者在12周和16周的给药间隔(不需要修改方案)中快速启动和维持到48周。
- 79%和77%的wAMD患者分别在12周和16周的给药间隔内快速启动和维持。
- AfLibercept 8 mg的安全性与Eylea相似，与Eylea在以前的临床试验中公认的安全性一致。
- AfLibercept 8 mg由Regeneron和拜耳股份公司(场外交易：BAYRY)。在美国，Regeneron保留了Eylea和afLibercept 8 mg的独家权利。拜耳已经授权了在美国以外的独家营销权，在美国，两家公司平均分享Eylea的销售利润。
- 价格行动：在周四的最后一次检查中，雷根的股价上涨了13.30%，达到675.77美元。