2015年3月16日讯 /生物谷BIOON/--所谓行百里者半九十，生物医药公司最为痛心的无疑是当投入了大量的人力物力完成一种药物的临床研发之后，被FDA拒之门外。而制药巨头默沙东最近则正在遭受这一“虐心”的经历。默沙东公司开发的麻醉药物sugammadex在经过近十年的坎坷之路后，最近极有可能再次被FDA拒之门外。
作为默沙东研发体系曾经的希望之星，公司对这种药物寄予厚望。默沙东公司是在收购Schering之后获得这一药物项目。上周五，默沙东公司透露FDA再次宣布推迟其原定下周公布的专家委员会表决。FDA表示希望默沙东公司能够提供sugammadex在超敏反应方面的研究数据。这表明FDA始终对这种药物可能引起的过敏反应耿耿于怀。根据相关规定，FDA将需要在2015年4月22日前作出进一步的决定。
Sugammadex的虐心之旅始于七年前，当时FDA因为过敏反应问题被FDA拒之门外。2013年，默沙东公司尝试再次敲响FDA的大门，结果铩羽而归。而此次sugammadex卷土重来是Roger Perlmutter继任默沙东公司的研发部门主管之后作出的重要决定。不过，现在看来或许是个不明智的决定。
不久之前，默沙东公司开发的肿瘤免疫疗法药物Keytruda获得FDA的批准而大获成功，被外界认为是默沙东公司研发部门业务重组初见成效。
详细英文报道：
Merck's anesthesia drug sugammadex has been cited repeatedly over the years as one of the top experimental meds in the pharma giant's ($MRK) pipeline, a trophy obtained in its megamerger with Schering. But the treatment has racked up a painful series of setbacks over the years, starting with its first rejection at the hands of the FDA 7 years ago and continuing now with a third looming rejection over unresolved questions surrounding a hypersensitivity study performed for its pitch to the agency.
After the markets closed on Friday, Merck put out a brief announcement saying that the FDA had decided to scrap an advisory committee review of sugammadex slated for next week.
"The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101)," noted Merck. "The agency has indicated it plans to conduct these additional inspections prior to an Advisory Committee meeting and completion of their review. Due to the timing of the additional inspections, Merck expects to receive a Complete Response Letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on April 22, 2015. Merck will continue to work with the FDA as it completes its review."
The news comes 21 months after the FDA scrapped the last adcomm meeting for sugammadex, citing the agency's desire to review a site involved in the troubled hypersensitivity study. Even with 7 years of discussions and applications with the FDA, Merck still can't overcome the agency's concerns about the allergic reactions that triggered the first rejection.
Merck's second rejection for this therapy in 2013 came during a particularly fallow period for the pharma giant, serving as a painful reminder of its inability to score significant new drug approvals. Roger Perlmutter's arrival as R&D chief, followed by Merck's big OK for the immuno-oncology drug Keytruda, helped dispel the bad rep that triggered a major R&D reorganization. But Perlmutter recently vowed--incorrectly--that sugammadex was back on track. The R&D chief also had to deal with the agency's decision to strip breakthrough drug status for a closely-watchedhep C program now that the first two game-changing therapies from Gilead ($GILD) and AbbVie ($ABBV) are already on the market. Perlmutter clearly found that a bitter pill to swallow. And Bristol-Myers Squibb ($BMY) recently leapfrogged Merck with its IO drug Opdivo, gaining a stunningly fast approval for lung cancer--a big market in the field.
Add it all up, and Merck's big R&D operation has had a rough start to the year.