Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year

Asserts Certara’s leadership in advancing the development and approval of new drugs for patients

PRINCETON, N.J.— 2023 年 4 月 27 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in biosimulation, today announced that 90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara’s customers in 2022.^* 这是 Certara 使用公司生物模拟软件和技术驱动服务的客户连续第 9 年有新药被 FDA 批准用于广泛的治疗适应症，从肿瘤到罕见疾病。

“Our biosimulation platform continues have an extraordinary impact on our client’s drug development programs and the industry at-large,” said Certara’s CEO William Feehery, Ph.D. “We remain committed to our mission of safely accelerating the drug development process by lowering the cost and increasing the probability of success in trials, to improve the health and well-being of millions of people, globally.”

Certara’s Simcyp™ PBPK Simulator has now been used to inform more than 300 drug label claims for over 100 novel drugs, in lieu of conducting clinical studies. Phoenix™ PK/PD software is also used extensively by biopharmaceutical companies to understand how a drug moves through and out of the body. Both Simcyp and Phoenix software are used by the FDA to evaluate drug applications. Certara’s technology-driven services, including model-informed drug development and regulatory writing and submission support, contributed to eight oncology drugs, two drugs for orphan diseases, two drugs that received priority review or accelerated approval in 2022, and one EUA for treatment of moderate/severe COVID-19.

View FDA Approvals for 2022

*excludes diagnostic agents

关于Certara

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.

联系人：
Ron DiSantis
ron.disantis@certara.com

媒体联系人：
Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com

Investor Relations Contact:
David Deuchler
Gilmartin Group
ir@certara.com