Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year
April 27 2023 - 8:00AM
Certara, Inc. (Nasdaq: 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.* This
is the 9th consecutive year that Certara’s customers, who use the
Company’s biosimulation software and technology-driven services,
have had novel drugs approved by the FDA in a wide range of
therapeutic indications, from oncology to rare diseases.
“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
About 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.
Certara Contact
Ron DiSantisron.disantis@certara.com
Media Contact:
Ariane LovellFinn Partnersariane.lovell@finnpartners.com
Investor Relations Contact:
David DeuchlerGilmartin Groupir@certara.com
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