2014年11月28日讯 /生物谷BIOON/ --常言道行百里者半九十。想必生物医药公司在经历大量繁琐的临床研究后，将所有数据提交给审批部门时就是这种心情。最近，制药巨头施贵宝公司就经历了这样的大起大落。
美国FDA在审核施贵宝公司提交的治疗丙肝药物daclatasvir相关数据后，认为施贵宝公司仍然需要补充更多数据，因而暂缓批准davlatasvir上市的请求。Daclatasvir是一种NS5A抑制剂。施贵宝公司和FDA并未透露过多细节，但面对瞬息万变的丙肝药物市场，FDA的这一决定无疑对施贵宝公司是一个重大打击。施贵宝公司研发主管Francis Cuss表示将和FDA通力合作，努力完成这一药物的审批过程。
早在几年前，施贵宝公司就开始努力对这一药物进行努力攻关，并宣称这一药物会对丙肝疗法起到革命性的改变。而施贵宝公司此前也取得了一些成绩，今年七月份，日本医药管理部门就批准了施贵宝公司daclatasvir和asunaprevir （ NS3/4A蛋白酶抑制剂）登陆日本市场，这也是首个登陆日本市场的丙肝鸡尾酒疗法，因而被施贵宝公司认为是公司丙肝药物研发部门的一项重大胜利。无独有偶，几乎同时，欧盟医药管理部门也对施贵宝公司的这一药物做出了高度评价。这些都使外界一度认为daclatasvir登陆美国市场只是时间早晚的问题。不过现在看来，FDA的要求要超出我们的想象。
即使退一步讲，daclatasvir真的如期上市，施贵宝公司也将面临巨大的竞争。前有吉利德公司的Sovaldi狙击，其后又有艾伯维、默沙东公司虎视眈眈。这些都将给施贵宝公司未来在丙肝药物市场的前景平添几分变数。
详细英文报道：
The FDA has slapped down Bristol-Myers Squibb's ($BMY) closely watched hep C drug daclatasvir, handing out a complete response letter for the linchpin drug in its cocktail strategy.
According to the big biotech, the initial marketing application for daclatasvir, an NS5A inhibitor, included its use in combination with the NS3/4A protease inhibitor asunaprevir--a combo that Bristol-Myers recently scuttled in the U.S. Now regulators are demanding more data for daclatasvir in combination with other antiviral agents for the treatment of HCV.
There's no immediate word on just how long the drug could be delayed in the U.S. before it hits the fast-changing hep C market. Bristol-Myers says it is "in discussions with the FDA about the scope of these data."
"Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the U.S. as quickly as possible," says Bristol-Myers R&D chief Francis Cuss.
Bristol-Myers--which fell behind Gilead's Sovaldi early on--had pursued an international development program for daclatasvir and asunaprevir, with a close eye on markets like Japan which have large populations of genotype 1b patients. The company won a landmark approval for the combo in Japan back in July, ushering in a new interferon-free regimen that is helping to rewrite the standard of care in the field.
Bristol-Myers was initially dealt a major blow when its nucleotide polymerase inhibitor--or "nuc"--blew up in the clinic a couple of years ago. Gilead, meanwhile, won an approval for a combination of Sovaldi (an NS5B blocker) and ledipasvir, its NS5A inhibitor. AbbVie and Merck have been working hard to close the gap with late-stage cocktails of their own that promise to further disrupt a market that has stunned payers with the introductory price of $84,000 for Sovaldi. That's a race that is squeezing out Bristol-Myers from the world's biggest drug market.