Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 9th Consecutive Year
Certara's Leadership in Drug Approvals
On April 27, 2023, Certara, Inc. (Nasdaq: CERT) announced that its clients achieved a remarkable milestone, with 90% of new drug approvals from the FDA's CDER in 2022. This marks the ninth consecutive year of significant FDA approvals for Certara’s clients, using its innovative biosimulation software across multiple therapeutic areas, including oncology and rare diseases.
Certara's Simcyp™ and Phoenix™ software have been instrumental in informing drug label claims and evaluating drug applications, respectively. Notably, these tools aided in the approval of eight oncology drugs among other critical treatments, reflecting Certara's commitment to enhancing drug development efficiency and safety for patients worldwide.
- 90% of new FDA drug approvals in 2022 were by Certara clients.
- This achievement marks the ninth consecutive year of significant FDA approvals.
- Certara's software contributed to approvals across diverse therapeutic areas.
- Simcyp™ PBPK Simulator helped inform over 300 drug label claims for more than 100 novel drugs.
- Technology-driven services supported eight oncology drugs and other treatments.
- None.
Asserts Certara’s leadership in advancing the development and approval of new drugs for patients
PRINCETON, N.J., April 27, 2023 (GLOBE NEWSWIRE) -- 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.
*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 DiSantis
ron.disantis@certara.com
Media Contact:
Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com
Investor Relations Contact:
David Deuchler
Gilmartin Group
ir@certara.com
FAQ
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