Case Study: KalVista Pharmaceuticals achieves FDA NDA acceptance for a novel HAE treatment with Certara

Supporting KalVista’s NDA Submission for a Novel HAE Treatment​

KalVista Pharmaceuticals, a biotech company, faced the challenge of preparing a New Drug Application (NDA) for its novel oral hereditary angioedema treatment under tight timelines. Lacking in-house expertise in complex modeling, they needed support for their submission and to expand the drug's label to pediatric populations. They partnered with Certara for its pharmacometrics and regulatory strategy services.

Certara provided integrated support, developing population PK, PK/PD, and exposure-response models to optimize dosing and trial design. The vendor also prepared submission-ready regulatory packages for the FDA and EMA. This resulted in the FDA accepting KalVista's NDA, enabled a strategy for pediatric label expansion, and increased regulatory confidence in the breakthrough therapy.

KalVista Pharmaceuticals