General Business

Certara Software or Services Supported 95% of FDA Novel Drug Approvals in First Half of 2018

Modeling and simulation’s positive impact on NDA and BLA approvals through July 1, 2018 has included first use, orphan and priority review drugs for multiple indications

Princeton-based Certara, a leader in model-informed drug development, regulatory science, market access and real-world evidence services, reported that 95% of novel new drug approvals by the US Food and Drug Administration (FDA) in the first half of 2018 were supported by Certara software or services. Those results emphasize how much modeling and simulation has become an integral part of regulatory submissions and highlight Certara’s leadership role in the field.

“Certara congratulates all of the biopharmaceutical companies that have achieved this hard-earned regulatory milestone and thanks them for giving us the opportunity to contribute to this success,” said Certara’s CEO Dr. Edmundo Muniz. “Our mission is to revolutionize the drug development paradigm by leveraging modern quantitative approaches such as modeling and simulation and real-world evidence solutions to optimize R&D productivity, commercial value and patient outcomes. These technologies’ positive impact is evident in the accelerated development cycles for these approved drugs and the innovation adoption by the FDA.”

FDA has been a leader promoting modeling and simulation as an integral part of drug development and review, highlighting it specifically in the 21st Century Cures Act, PDUFA VI and GDUFA II. Further illustrating that point, FDA Commissioner Scott Gottlieb, MD, cited “the more widespread use of modeling and simulation, the greater use of real-world evidence in the pre- and post-market setting, and the adoption of better tools for collecting and evaluating more real-time safety information after products are approved” among the new scientific domains that have been introduced into the development and review process in a recent statement.

Among the 2018 novel drug approvals for which Certara’s modeling and simulation technology-enabled services were leveraged, the following examples are illustrative of innovation:

  • Medicines Development for Global Health’s (MDGH’s) approval for moxidectin for onchocerciasis (river blindness). River blindness is caused by the filarial worm Onchocerca volvulus, which is transmitted through infected black fly bites. At least 25 million people are infected with Onchocerca volvulus worldwide, according to the World Health Organization. Moxidectin is the first new drug approved for river blindness in 20 years. MDGH is also the first not-for-profit company to be awarded a priority review voucher by the FDA.
  • Ultragenyx Pharmaceutical Inc’s approval of Crysvita (burosumab-twza), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. According to Dr. Julie Beitz of the FDA, “XLH differs from other forms of rickets in that vitamin D therapy is not effective. This is the first FDA-approved medication for the treatment of XLH and a real breakthrough for those living with this serious disease.”
  • GW Pharmaceuticals’ approval for Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA-approved drug for the treatment of patients with Dravet syndrome.

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