吉利德（Gilead）对已在欧洲授权 2 年的 D 型肝炎药物意外地

StephenW

吉利德（Gilead）对已在欧洲授权 2 年的 D 型肝炎药物意外地被 FDA 拒绝
凯文·邓利维
2022 年 10 月 28 日 09:52
Gilead Sciences FDA 完整的丁型肝炎回复信


2020 年 12 月，当吉利德收购德国的 MYR 及其丁肝病毒药物（该药物已获准在欧洲使用）时，这家加利福尼亚公司表示将“加速”该疗法的全球推出。

近两年后，吉利德尚未在美国获得这种名为 bulevirtide 的药物的批准，而且随着 FDA 的反对，这种情况不会很快发生。

在其完整的回复信中，监管机构引用了该药物的制造和交付问题。该公司在周四下午公布其第三季度收益时透露了拒绝。

“我们将花时间完全消化 CRL，但请注意 FDA 没有要求进行新的安全性或临床试验，”吉利德的首席医疗官 Merdad Parsey 医学博士在电话会议上表示。 “我们计划尽快重新提交，我们将在前进的道路上与该机构合作。”

这是吉利德 8 个月内第二次与制造相关的 CRL，该公司还在 3 月份收到了 FDA 拒绝接受 HIV 潜在药物 lenacapavir 的通知。在吉利德改变产品的小瓶以解决相容性问题后，FDA 最近接受了对长效 HIV 候选药物的重新申报。这种药物上个月在欧洲和英国获得了批准。

至于布列韦肽，进入抑制剂是吉利德11.5亿欧元收购马币的关键一环。它于 2015 年在美国获得孤儿药地位，并于 2020 年 9 月以 Hepcludex 品牌在欧洲推出。

今年 6 月，吉利德公布了一项试验结果，该试验结果显示，经过 48 周的治疗，病毒显着下降。这种情况被称为卫星病毒，因为它只感染乙型肝炎患者。

丁型肝炎感染了大约 5% 的乙型肝炎患者，即全世界大约 1200 万，并且通常是致命的。 Hepcludex 是该病毒的第一种可用治疗方法，该病毒通过性接触或接触受污染的注射器通过破损的皮肤传播。

StephenW

Gilead hits surprise FDA rejection for hepatitis D drug already authorized in Europe for 2 years
By Kevin Dunleavy
Oct 28, 2022 09:52am
Gilead Sciences FDA Complete Response Letter hepatitis D


In December of 2020, when Gilead acquired MYR of Germany and its hepatitis D virus drug—which was already authorized for use in Europe—the California company said it would “accelerate” the global launch of the treatment.

Nearly two years later, Gilead has yet to gain sanction for the drug, called bulevirtide, in the U.S., and it’s not happening any time soon as the FDA has given it a thumbs down.

In its complete response letter, the regulator cited manufacturing and delivery concerns with the drug. The company revealed the rejection on Thursday afternoon as it presented its third quarter earnings.

“We will take the time to fully digest the CRL but note that no new safety or clinical trials were requested by the FDA,” Gilead’s chief medical officer Merdad Parsey, M.D., Ph.D., said in during a conference call. “We plan to resubmit as quickly as possible and we’ll work with the agency on the path forward.”

It is the second manufacturing-related CRL in eight months for Gilead, which also got an FDA rejection notice for HIV prospect lenacapavir in March. The FDA has recently accepted a refiling for the long-acting HIV candidate after Gilead changed the product’s vial to fix a compatability problem. That drug was sanctioned in Europe and the U.K. last month.

As for bulevirtide, the entry inhibitor was the key piece in Gilead’s purchase of MYR for 1.15 billion euros. It received orphan drug status in the U.S. in 2015 and was launched in Europe under the brand name Hepcludex in September of 2020.

In June, Gilead released results of a trial that showed it provided significant viral declines after 48 weeks of treatment. The condition is referred to as a satellite virus because it only infects those with hepatitis B.

Hepatitis D infects roughly 5% of those with Hepatitis B, or roughly 12 million worldwide and is often fatal. Hepcludex is the first treatment available for the virus, which is transmitted through broken skin via sexual contact or contact with tainted syringes.