PRESS RELEASE

Certara software or services support 95 per cent of the US FDA novel drug approvals in the first half of 2018

Certara has reported that 95 per cent of novel new drug approvals by the US Food and Drug Administration (FDA) in the first half of 2018 was supported by Certara software or services. These results emphasise the importance of modelling and simulation which has become an integral part of regulatory submissions.

‘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 revolutionise the drug development paradigm by leveraging modern quantitative approaches such as modelling and simulation and real-world evidence solutions to optimise 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 promoted the use of modelling 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 modelling 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
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