The Year 2020 Marks the 7th Consecutive Year Certara Customers Received 90 Percent of US FDA Novel Drug and Biologic Approvals
Certara, Inc. (Nasdaq: CERT) reported that 2020 was the seventh consecutive year where 90% of new drug and biologic approvals by the FDA were by its customers. In total, the FDA approved 54 new medicines in 2020, many of which received orphan and breakthrough designations. Certara’s biosimulation platforms, including Simcyp™, Phoenix™, and GlobalSubmit™, have been pivotal for drug development, enabling the provision of drug label claims without extensive clinical studies. CEO William Feehery highlighted the company's role in transforming drug development through advanced modeling techniques.
- 90% of FDA drug approvals in 2020 were for Certara's customers, showcasing strong client impact.
- Certara's software platforms are widely adopted by over 1,650 clients globally, enhancing R&D efficiency.
- The Simcyp Simulator facilitated approximately 250 drug label claims, reducing the need for extensive clinical studies.
- None.
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 2020 marked the seventh consecutive year where
In 2020, the FDA’s Center for Drug Evaluation and Review and the Center for Biologics Evaluation and Research approved 54 medicines, excluding diagnostic agents. The majority of new drug approvals had orphan drug designation, and approximately half had breakthrough therapy designation.
Certara’s Simcyp™, Phoenix™ and GlobalSubmit™ software platforms have been broadly adopted by the biopharmaceutical industry and global regulatory agencies for drug development and regulatory review. The Simcyp Simulator has now been used to provide approximately 250 drug label claims for more than 75 novel drugs, in lieu of conducting clinical studies. In 2020, the Simcyp Simulator was included in the regulatory submissions for therapies to treat breast cancer, a rare pediatric disease, and gastrointestinal tumors, among others.
“This milestone is indicative of Certara’s impact in transforming the traditional drug development process, which can be costly and take many years,” said Certara’s CEO William Feehery, PhD. “We are proud to be at the forefront of a long-term trend of computer-based modeling that has advanced new treatments in a wide range of therapeutic areas, such as oncology, neurology, and rare diseases. In particular, our unique Simcyp Simulator has allowed our sponsor partners to expand prescribing information for novel drugs with regulatory-accepted science based on biosimulation.”
About Certara
Certara accelerates medicines using biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.
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