Correvio Pharma Considering Sale Amid FDA Headwinds on Cardiovascular Drug

Corvio Pharma 考虑在 FDA 销售心血管药物

2019-12-13 10:42:17 BioSpace

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Correvio Pharma Corp., based in Vancouver, British Columbia, indicated that it is considering a sale after a U.S. Food and Drug Administration (FDA) advisory committee voted against approving its Brinavess (vernakalant hydrochloride, IV). This is an antiarrhythmia drug for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults. Brinavess is already approved for marketing in Europe, Canada and several other countries. It is approved in the EU for rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults for non-surgery patients who had AF less than 7 days duration, for post-cardiac surgery patients with AF less than 3 days duration. It is not yet approved in the U.S. Correvio has a target action date of December 24, 2019 for its resubmitted New Drug Application (NDA) for Brinavess. However, the FDA advisory committee met and voted 11 to 2 against recommending approval of Brinavess, citing safety concerns. The FDA is not required to follow the recommendations of its adcoms, but typically does. The NDA was built on data from SPECTRUM, a post-authorization safety study conducted in Europe of 1,778 unique patients across a total of 2,009 treatment episodes after dosing of Brinavess. The data showed that Brinavess successfully converted 70.2% of the treated AF patients into normal sinus rhythm. It also demonstrated a median time to conversion of 11 minutes from the start of the first infusion in the patients who were successfully converted. “Given yesterday’s FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting outcome for Brinavess (vernakalant IV) for the conversion of atrial fibrillation (AF), we believe it is in the best interest of our stakeholders to expand our internal corporate development efforts and formally evaluate strategic alternatives for the company,” said Mark H.N. Corrigan, Correvio’s chief executive officer. Corrigan added, “We have a strong and growing commercial portfolio of assets being sold across the globe and we will immediately begin preparations for a potential strategic transaction while we await the U.S. Food and Drug Administration (FDA)’s decision regarding Brinavess. We are also taking steps to reduce operating costs outside the core European commercial business and a transaction committee has been formed within the Board of Directors.” The adcom’s vote was an indication they did not believe the benefit-risk profile of the drug was enough to support approval. The company’s commercial portfolio outside the U.S. is expected to bring in about $30 million in revenue this year. That portfolio is made up of four approved and commercialized branded products and one product candidate. They are Xydalba (dalbavancin hydrochloride) for acute bacterial skin and skin structure infections; Zevtera/Mabelio (ceftobiprole medocaril sodium), an antibiotic for community- and hospital-acquired pneumonia; Brinavess; Aggrastat (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome; and Trevyent, a drive device combination that delivers treprostinil, a treatment for pulmonary arterial hypertension. Correvio has hired Piper Jaffray to help review its strategic options. Without indicating whether it expected job cuts, the company stated it planned to reduce its operating costs in North America. This way it would focus its resources on essential commercial and business development activities. Correvio has made attempts to get approval for Brinavess in the U.S. since 2006. The FDA has never approved it because of safety concerns. At one point the U.S. trials were placed on hold after the death of a patient. The clinical hold is still in place. In a 2014 research and review paper in Current Cardiology Reviews, John Camm, with St. George’s University of London, UK, wrote, “The terms of the [European] approval are very strictly aligned to the evidence base for vernakalant. … Regulators were able to label the drug to avoid the majority of other adverse effects of vernakalant offered an alternative to amiodarone in patients with mild or moderate heart disease. Although amiodarone achieves conversion in a high proportion of patients its action is relatively delayed. A clear unmet need could potentially be filled by this new antiarrhythmic drug.” Although the paper is five years old, Camm’s conclusion likely holds today: “The difference between regulatory opinions on both sides of the Atlantic is disturbing and perplexing. Agencies in Europe and the USA came to different conclusions when examining the same evidence-base. Thus, neither opinion can be entirely or easily accepted.”
总部位于不列颠哥伦比亚省温哥华的 Corvio Pharma Corp .表示,在美国食品药品监督管理局(Food and Drug Administration)( FDA )咨询委员会投票反对批准 Brinaess (盐酸文雅兰, IV )之后,该公司正在考虑出售。这是一种抗心律失常药物,用于快速转换近期发作的心房颤动( AF )到成人窦性心律。 Brinaviess 已经被批准在欧洲、加拿大和其他几个国家进行营销。经欧盟批准,对于房颤持续时间小于7天的非手术患者,对于房颤持续时间小于3天的心脏手术后患者,可迅速将近期发作的房颤转换为成人窦性心律。它尚未在美国获得批准。 Correvio 因再次提交 Brinavity 的新药申请( NDA ),其目标行动日期为2019年12月24日。然而, FDA 咨询委员会召开会议,以安全问题为由,以11票对2票反对建议批准 Brinavice 。FDA 不需要遵循其 adcoms 的建议,但通常是这样做的。 NDA 建立在 SPECTRUM 的数据基础上,这是一项在欧洲进行的授权后安全性研究,共有1,778名患者在给药后进行了2,009次治疗。数据显示, Brinavaess 成功地将70.2%的治疗房颤患者转化为正常的窦性心律。它还显示了从第一次输注开始到成功输注的患者转换11分钟的中间时间。 “考虑到昨天 FDA 心血管和肾脏药物咨询委员会( CRDAC )召开的关于心房颤动( AF )转换的 Brinavity ( vernakalantIV )会议结果,我们认为扩大我们的内部企业发展努力并正式评估公司的战略替代方案符合我们的利益。”Correvio 首席执行官马克· H · N ·科里根( Mark H.N . Corrigan )说。 科里根补充说,“我们在全球范围内拥有强大且不断增长的商业资产组合,我们将在等待美国食品药品监督管理局(Food and Drug Administration)( FDA )关于 Brinavice 的决定时,立即开始准备潜在的战略交易。我们还在采取措施降低核心欧洲商业业务之外的运营成本,并在董事会内成立了交易委员会。” ADcom 的投票表明,他们不认为该药的效益风险状况足以支持批准。 该公司在美国以外的商业投资组合预计今年将带来约3000万美元的收入。该产品组合由四个核准和商业化的品牌产品和一个产品候选人组成。它们是用于急性细菌性皮肤和皮肤结构感染的 Xydalba (盐酸达拉巴万西汀); Zevtera / Mabelio (头孢妥比星米多卡利钠),一种用于社区和医院获得性肺炎的抗生素; Brinaess ; Aggrastat (盐酸替罗非班)用于急性冠脉综合征患者血栓心血管事件的减少; Trevyent ,一种驱动装置的组合,提供 treproinil ,治疗肺动脉高压。 Corvio 已经聘请 Piper Jaffray 帮助审查其战略选择。在没有说明是否预计裁员的情况下,该公司表示计划降低北美的运营成本。这样,它将把资源集中用于基本的商业和商业发展活动。 自2006年以来, Corvio 一直试图获得美国海军陆战队的批准。由于安全问题, FDA 从未批准过它。在某一时刻,美国的试验在病人死亡后被搁置。临床坚持仍在进行中。 在2014年的一篇研究和评论论文中,约翰·卡姆,与圣帕特里克斯。英国伦敦大学( University of London )的乔治( George )写道:“(欧洲)批准的条款非常严格地与本地人的证据基础一致。…在轻度或中度心脏病患者中,监管者能够给该药贴上标签,以避免游手好闲的大部分其他不良反应。虽然胺碘酮在很大一部分患者中实现了转化,但其作用相对滞后。这种新的抗心律失常药物有可能满足未得到满足的明显需求。” 尽管这篇论文有五年的历史,但卡姆的结论可能在今天得出:“大西洋两岸监管观点之间的差异令人不安和困惑。欧洲和美国的机构在审查同一证据基础时得出了不同的结论。因此,两种观点都不可能完全或容易被接受。”

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