CDER Officials: Nanomaterial Submissions on the Rise

Posted 27 April 2017 | By Michael Mezher

CDER Officials: Nanomaterial Submissions on the Rise

A team of officials from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER) say that submissions for drugs containing nanomaterials are on the rise.

The finding stems from an analysis published Monday in Nature Nanotechnology, in which the officials look at trends in submissions involving nanomaterials over the last 40 years.

In the analysis, the authors say the number of investigational new drug applications (INDs), new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for products containing nanomaterials has increased steadily, from a trickle in the 1970s and early '80s to 20 or more per year for much of the last decade.

Nanomaterials can serve a variety of functions within a drug, from active pharmaceutical ingredients to novel excipients and drug carriers.

According to the authors, of the 234 INDs CDER has received for products containing nanomaterials, 44 (19%) ended up being reviewed under an NDA by the agency.

Of those, 34 NDAs for drugs containing nanomaterials have gone on to be approved by the agency, or roughly 15%, which the authors say is comparable to the first cycle approval rate for all NDAs and biologics license applications (BLAs).

"As these products are reviewed in the same manner as products not containing nanomaterials, the results are especially noteworthy, because this indicates that the inclusion of nanomaterials does not hinder the regulatory review and approval of drug products, which has sometimes been asserted," the authors write.

Liposomes used as drug carriers were by far the most common type of nanomaterial, accounting for 33-35% of all nanomaterial-containing submissions since the 1970s, followed by nanocrystals, which accounted for 20-29% submissions.

The popularity of liposomes, the authors write, "may be due, in part, to the early success of this platform, its versatility and the fact that some of the original patent protections and/or marketing exclusivity provisions have expired."

Cancer was found to be the most common therapeutic target for nanomaterial containing products and accounted for 61% of products containing liposomes.

"Nanomaterials are able to prolong circulation times, reduce the volume of distribution and drug accumulation at healthy non-target tissues, and increase drug localization at the tumor target site through either passive or active targeting," the authors write.

Nature Nanotechnology


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