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Gilead: 抗乙肝新药Vemlidy 获得FDA批准上市！
终于批准了， Gilead 一年前就放出了风声，这个药物的临床效果不错， 虽然不及治疗丙肝的Harvoni 那么革命行的效果， 但对于乙肝患者而言这也是最新的突破了。 不知道标上的价码会有多高，有多少人可以支付得起。 但我们美国好大夫有10 几位美国执业的消化内科专家，及100 多位全科，或者家庭科大夫都可以帮助您获得这个最新的药。 我们签约的药房也可以获得这个新药。 欢迎垂询！
昨天，Gilead Sciences公司宣布，美国FDA已经批准其新药产品Vemlidy（tenofovir alafenamide，TAF）25mg，每日一次治疗伴有代偿性肝病的慢性乙型肝炎病毒（HBV）感染。
Vemlidy是一种创新型、靶向性、tenofovir前药，与Gilead的先前产品 300mg的Viread (tenofovir disoproxil fumarate, TDF)相比， 只需要少于十分之一的剂量就可达到类同的抗病毒功效。临床数据显示，与Viread相比，Vemlidy具有更大的血浆稳定性而且可更有效地将tenofovir递送到肝细胞，所以可以使用更低的给药剂量，导致血液中富含更少的tenofovir。因为上述原因，与Viread相比，Vemlidy有效改善了针对肾脏和骨骼的安全性参数。
Vemlidy的获批来自两个国际型3期临床试验（研究108和研究110）的长达48周的数据支持，总共涉及了1298名初治和有过治疗的慢性HBV感染成人患者。研究108使用Vemlidy或Viread随机化治疗了425例HBeAg阴性患者，研究110使用Vemlidy或Viread随机化治疗了873名HBeAg阳性患者。两个研究都达到了它们的主要临床研究终点：在治疗第48周时，基于血浆HBV DNA水平低于29 IU/mL的慢性乙型肝炎患者的百分比这一指标，Vemlidy显示出了相对Viread的非劣效性。
在两个研究的综合分析中，与使用Viread治疗的患者相比较，接受Vemlidy治疗的患者在某些骨骼和肾脏的参数方面得到改善。在血清丙氨酸氨基转移酶（ALT）水平的正常化速率上，Vemlidy组中的患者的数值也更高。Vemlidy和Viread在两项研究中都耐受性良好。
Gilead Sciences公司总裁兼首席执行官John Milligan博士说道：“自20世纪90年代中期以来，Gilead一直致力于改善和简化慢性乙型肝炎患者的医疗护理。Vemlidy是近十年内被批准用于治疗这种疾病的首个药物，我们很高兴能提供一个新的有效选择，以帮助促进患者的长期护理。”
Gilead Sciences, whose hepatitis C dynasty has been slipping, has won approval for its next-gen hepatitis B treatment.
The Foster City, CA-based drugmaker said Thursday that the FDA had approved Vemlidy, a once-daily treatment for adults with chronic hepatitis B virus (HBV) with compensated liver disease. The drug, however, comes with a black-box warning for risks.
Gilead ($GILD) already has a hep B treatment, Viread, but said today that the new drug can be given at one-tenth the dose of Viread and so has better renal and bone laboratory safety parameters than its predecessor.
Dr. Calvin Pan, a clinical professor of medicine at NYU Langone Medical Center and an investigator in the Vemlidy clinical trials, said the improved renal and bone safety parameters were an important development for the 2.2 million people in the U.S. suffering from the life-threatening disease.
The approval comes at a time when Gilead’s one-time powerhouse hep C treatments Sovaldi and Harvoni have fallen victim to competition and payer discounting, with sales plummeting 31% for the last quarter. The results missed consensus estimates by 3%, even with help from the recent rollout of Epclusa, a regimen that spans all hep C genotypes.
Investors are still looking for Gilead to buy something significant that can pull it out of the dive, as it did when it acquired the asset that turned into Sovaldi and Harvoni. It was rumored to be looking at cancer biotech Medivation, but blocked folks from the deal with a $14 billion bid.
CEO John Milligan told investors that the company is “currently very, very active” in looking for M&A deals but will only “do things when they make sense for us and not before then.”
Editor's Note: The story was updated with information about the EU's CHMP recommending Vemlidy.
参考资料：
[1] U.S. Food and Drug Administration Approves Gilead’s Vemlidy® (Tenofovir Alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection
[2] Gilead官方网站