FDA Name Approvals – 2019 in Review

Overview

Last year saw the FDA approve no less than 48 new molecular entities and new therapeutic biological products, so-called “novel” drugs. 21 of these treatments were designated to have “orphan” status reflecting significant advances across an extensive spectrum of rarer diseases and conditions.

And, consistent with recent years, 2019 heralded the approval of a high number of cancer and blood disorder drugs in multiple oncological and hematological areas.

A significant number of biosimilars also gained approval helping to reduce costs as well as increase patient access to important therapies.

 

Wide variety of name types

Different approaches to drug nming are seen within a broad range of communication and messaging strategies, including:

INN/USAN-referential tradenames such as Trikafta (encodes triple combination ~caf~ infixed CFTR modulators), Brukinsa (zanubrutinib), Givlaari (givosiran), Oxbryta (voxelotor) and Ubrelvy (ubrogepant) which, by echoing nonproprietary origins, can help prescribers both identify and recall drug provenance and functionality

Indication-suggestive or condition-related names such as Aklief (“acne relief”), Ibsrela (“irritable bowel syndrome”), Beovu (“better view”), Scenesse (“scene”, “essence”), Dayvigo (“overcome insomnia”), Wakix (“stay awake”) and Fetroja (embeds “Fe” [iron] and “Trojan horse” MOA cues) can offer definitive and therapy-specific benefit associations

Apparently arbitrary/meaningless coined names, although maybe less immediately intuitive than more identifiably apparent names, can deliver long-lasting distinctiveness and stand-out value by incorporating unorthodox or deliberately unusual letter strings or underrepresented syllables, such as Xcopri, Rinvoq, Piqray and Turalio

Aspirational, or imagery-indicative, drug names can help evoke positive and beneficial emotional, and actual, product connotations which may be relevant both to patients as well as medical professionals alike, such as Jeuveau (“rejuvenation), Mayzent (“amazing”, MS), Balversa (“balance”, “versatility”) and Skyrizi (“sky”, “rise”), and Vyndaqel (“vindicate”, “quell”).

 

Innovation primacy

Of the 48 “novel” drug approvals in 2019, 20 were first-in-class treatments meaning they offer different mechanisms of action (MOAs) from existing therapies including Adakveo, Balversa, Cablivi, Evenity, Givlaari, Ibsrela, Nourianz, Oxbryta, Padcev, Polivy, pretomanid, Reblozyl, Reyvow, Scenesse, Turalio, Vyleesi, Vyndaqel, Wakix, Xpovio, and Zulresso.

It is widely expected that such development innovation will continue into the new decade and name creation for such pharmacologically-inventive products will need to provide equal levels of ingenuity in terms of inspiration, distinctiveness and overall impact.

 

To contact Purple Fire Branding, specialists in brand naming, research and design, please telephone +44 (0)20 8166 1853 or visit www.purplefirebranding.com