Certara Customers Received 90 Percent of US FDA Novel Drug Approvals for 8th Consecutive Year
Certara announced that in 2021, 90% of new drug approvals from the FDA’s CDER were achieved by its customers, marking the eighth consecutive year of success in drug approval for clients utilizing its biosimulation software. The company’s Simcyp™ Simulator played a significant role in providing prescribing information for 13 new drugs, thereby reducing clinical trial costs and durations. Certara's technology has been instrumental in supporting the approval process for various therapeutic areas including oncology and orphan diseases, reinforcing its position as a leader in drug development.
- 90% of new drug approvals by the FDA in 2021 were for Certara's customers.
- Eighth consecutive year of drug approvals for clients using Certara's technology.
- Simcyp™ Simulator contributed to the approval of 13 new drugs, aiding in cost reduction for clinical trials.
- Technology used for evaluating drug applications by FDA and supporting diverse therapeutic areas.
- None.
Asserts Certara’s leadership in advancing the development and approval of new drugs for patients
PRINCETON, N.J., Feb. 15, 2022 (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 2021, excluding diagnostic agents. This is the 8th 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.
“We are proud of our contributions to advance new medicines using our biosimulation software and technology-driven services,” said Certara’s CEO William Feehery, Ph.D. “This past year, we worked with large pharmaceutical companies and biotechnology companies to support many first-in-class therapies, which have mechanisms of action different from those of existing therapies. Furthermore, our Simcyp™ Simulator aided in providing prescribing information for 13 new drugs in 2021, helping to mitigate the cost and time required with clinical trials.”
Certara’s Simcyp PBPK Simulator has now been used to inform more than 250 drug label claims for nearly 90 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. Additionally, Certara’s technology-driven services, including model-informed drug development and regulatory writing and submission support, contributed to 6 oncology drugs, 14 drugs for orphan diseases and 17 drugs that received priority review or accelerated approval in 2021.
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
Jieun W. Choe
jieun.choe@certara.com
Media Contact:
Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com
Investor Relations Contact:
David Deuchler
Gilmartin Group
ir@certara.com
FAQ
What percentage of new drug approvals by the FDA in 2021 were from Certara's customers?
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Which therapeutic areas benefited from Certara's services in 2021?
