FDA sees growing interest, uptick in INDs containing nanomaterials

Regulatory NewsRegulatory News | 13 October 2022 |  By 

To increase chances of product approval, sponsors of drugs containing nanomaterials should identify the risk level of their products and plot out a strategy to mitigate these risks, asserted an official from the US Food and Drug Administration (FDA) at a 11 October symposium sponsored by the FDA’s Small Business and Industry Assistance (SBIA).
Officials also noted a growing number of submissions for drugs containing nanomaterials and greater interest in commercializing these products at an update on the agency’s nanotechnology development program.
“I’ve enjoyed watching this field evolve, beginning with the time when we struggled simply to define nanotechnology,” said Douglas Throckmorton, deputy director for regulatory programs at FDA’s Center for Drug Evaluation and Research (CDER).
CDER received more than 800 investigational new drug applications (INDs) for nanomaterial-containing products, while 77 nanomaterial products have been approved for human use, which Throckmorton called a “tremendous” accomplishment. This represents a significant increase from the 234 nanomaterial INDs submitted in 2017. (RELATED: CDER Officials, Nanomaterial Submissions on the Rise, Regulatory Focus 27 April 2017)
FDA’s Anil Patri, FDA’s nanocore director concurred. “This is an exciting field with new innovations and solutions to global problems.” He noted that government spending reached 9 billion this year on nanotechnology and “there is increased interest in supporting lab-to-commercial market initiatives.”
Patri further noted that “there has been an evolution of these products from simple delivery systems to complex delivery systems.”
Some of the nanomaterial drug approvals include Jazz Pharmaceuticals’ Vyxeos (daunorubicin and cytarabine) for treating acute myeloid leukemia in 2017; Ipsen’s Onivyde (irinotecan liposome injection) approved in 2015 for pancreatic cancer; Talon Therapeutics’ Marqibo (vincristine sulfate liposome injection) approved in 2012 for acute lymphoid leukemia; Bristol Myers Squibb’s Abraxane (paclitaxel protein-bound particle for injectable suspension) approved in 2005 for several cancers; OSI Pharmaceuticals’ Macugen (pegaptanib sodium) approved in 2004 for macular degeneration; and Gilead’s AmBisome (amphotericin B) approved in 1997 as an antifungal.
In the biologics space, Pfizer and BioNTech’s mRNA COVID-19 vaccine Comirnaty was approved in 2021 and is derived from lipid nanoparticles.
According to FDA, liposomes, which are used in cancer treatment, were the most prevalent type of nanomaterials used in approved products. These accounted for 33% of submissions from 1973 to 2015, followed by nanocrystals, accounting for 23% of submissions.
Know the risk
One of the more important takeaways from FDA’s April final guidance on nanomaterials is that sponsors should know which risk category their product is classified as – either high-, medium-, or low-risk – and to outline a risk mitigation strategy commensurate with these risks, said FDA’s Olen Stephens, a chemist with FDA’s Office of New Drug Products. (RELATED: FDA finalizes guidance for drugs and biologics containing nanomaterials, Regulatory Focus 25 April 2022)
“Make a rational, scientific argument based on the data to demonstrate the potential benefit of conducting a clinical trial that outweighs the risk to the individual patients,” said Stephens. “Show you understand the product and the unknowns. Enumerate the failure modes and the safeguards you have in place.” These safeguards can include clinical monitoring or strict handling precautions. The benefits can include meeting an unmet need or a first in its class technology.
Stephens also urged sponsors to seek pre-IND meetings with FDA, especially if they are unsure of the risk classification of their products. He said these meetings, which are free, provide sponsors with some of the “best forms of advice.”
At these meetings, sponsors should provide a “clear description” of the product’s design and should show their batch data. Also, he advised sponsors to “be upfront about [their product’s] residual risk.”
SBIA symposium on nanomaterials


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you