FDA starts pilot after AstraZeneca, J&J make case for novel drug delivery excipients

FDA Building 2
The FDA is accepting proposals for an excipient manufacturer pilot project until Dec. 7. (FDA)

Academic literature features a steady stream of papers on novel excipients with the potential to improve drug delivery, but they rarely show up in newly approved drugs because companies shy away from the additional risk they entail. Recognizing that, the FDA has created a Novel Excipient Review Pilot Program to clear the logjam. 

Multiple drug developers used the FDA’s call for comment on the proposed program late in 2019 to set out the drug delivery applications of novel excipients. Johnson & Johnson highlighted how the viscosity and protein instability of biologics at high concentrations restricts the ability of formulators to develop drugs in more convenient at-home subcutaneous injection formats. 

J&J said “recent literature has highlighted numerous novel excipients that reduce the viscosity of high concentration proteins.” If biopharma companies could use those excipients, it “would greatly aid in the development of subcutaneous injected therapies for home administration,” the company said. 

Companies including AstraZeneca and Ultragenyx Pharmaceutical picked out other drug delivery use cases for excipients. Ultragenyx highlighted particle-based drug delivery excipients while AstraZeneca reeled off a string of applications including intracellular delivery, nucleic acid based therapeutics and improvements to parenteral and inhaled administration. 

RELATED: FDA starts pilot to help sponsors use novel trial designs

The companies are now a step closer to realizing the drug delivery potential of novel excipients, but other groups need to put in work before new products come to market. The FDA has the process underway with a call for applications from excipient manufacturers to join a pilot program.

Over two years, the FDA will evaluate four proposals through the pilot program. The excipients must never have been used in FDA-approved drugs nor have an established use in food. Beyond those core criteria, the FDA is looking for proposals from manufacturers that can supply the required package and that have the potential to deliver public health benefits and improve pharmacokinetics. 

The FDA is accepting proposals for the pilot project until Dec. 7.