Gilead Sciences (GILD) said Monday its two applications for lenacapavir as a pre-exposure prophylaxis to prevent HIV have been validated for parallel accelerated review by the European Medicines Agency.
The company said one application is for a marketing authorization and another is an EU-Medicines for all, or EU-M4all, application to facilitate expedited review processes for the injectable HIV-1 capsid inhibitor in other countries outside the EU.
Both applications are supported by phase 3 data that showed twice-yearly lenacapavir achieved risk reduction in HIV infections of 96% to 100%, the company added.
Gilead Sciences said the EMA validation followed the acceptance by the US Food and Drug Administration of its new drug applications for lenacapavir.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。