New drug for medical burnout

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"FDA approves first novel drug to treat medical burnout":

TWISP, WA – The US Food and Drug Administration today approved Peaceaudi (Idongivafumab) injection for intravenous use for the treatment of medical burnout.

"Medical burnout is a serious condition, which affects thousands of doctors across the country. The effects of burnout have untold consequences, and could significantly shorten the careers of physicians if untreated," said Arnold J. Palmer, MD, assistant to the regional manager for drug development of the FDA.

"This announcement marks the first time a drug has been specifically approved to treat medical burnout. Idongivafumab's unique ability to target and inhibit C-suite peptides, as well the entire electronic health record (EHR) cascade, represents a quantum leap in burnout science."

[…]

Due to molecular instability, Idongivafumab can only be administered as a continuous infusion in locales of extreme tranquility. As of press time, the only locations certified to be sufficiently tranquil for use of Idongivafumab were in Tahiti, the Maldives, or the Deplar Farm Hotel in Iceland.

After a two-week treatment course, subjects reported positive effects lasting at least 3 weeks, and even up to 6 weeks. A repeat treatment course was required in 24% of tests subjects. With a typical cost of treatment estimated to cost $212,000, the makers of Idongivafumab are working to ensure that this new treatment will be covered by all major insurance carriers.

For background on the naming choice Idongivafumab, see "Sorting Through the Confusion of Biologic Drug Names", which explains that 

Monoclonal antibody names have four segments (and usually five syllables). The first segment is the decision of the drug developer. The next segment is the target or disease class, to which a vowel may be added to allow pronunciation (Table 1). Before 2009, tumor-specific segments were used, but this practice has been discontinued because most monoclonal antibodies with oncology indications are investigated for more than one type of tumor. The third segment of the name indicates the source (eg, human, mouse) and is useful for predicting immunogenicity. The last syllable is "mab," for "monoclonal antibody."

Thus Alirocumab, Datatumumab, Dinutuximab, Elotuzumab, Idarucizumab, etc.

 



8 Comments

  1. Rose Eneri said,

    August 1, 2019 @ 2:28 pm

    Joking aside, Wikipedia has a more thorough explanation of the naming convention for monoclonal antibodies at:

    https://en.wikipedia.org/wiki/Nomenclature_of_monoclonal_antibodies

  2. Viseguy said,

    August 1, 2019 @ 9:52 pm

    The real money, I imagine, is in coming up with the tradenames (Praluent, Darzalex, Unituxin …). How much did Esso pay for Exxon? I seem to remember that it was quite a lot. (And why was Mobil ultimately not so mobile?) More to the point, what makes a highly desirable, marketable tradename? Way back when, I was sure that Verizon would be a flash in the pan. Are there rules for what's likely to work, and what isn't?

  3. Peter S. Shenkin said,

    August 1, 2019 @ 10:01 pm

    Let's play this game backward.

    Deconstruct "traintothezumab"

    -P.

  4. Ursa Major said,

    August 2, 2019 @ 7:01 am

    The naming of drugs is a quite complicated process that involves a lot of commercial politics.

    Aside from all the pre-drug names for a chemical compound (systematic names, semi-systematic names, trivial names, code names, etc.), every drug has at least two names: the generic name and the trade name(s).

    The generic name is intended to be universal, so physicians, pharmacists and patients can be sure they are taking the right drug. The two main naming systems are the INN and the USAN usually now make sure they use the same name, but historically they have occasionally assigned different names, which can cause problems for people travelling in or out of the US (paracetamol/acetaminophen is probably the best-known example).

    As the links posted by Rose and in the OP say, the generic name, of which idongivafumab is a parody, is built up systematically from various elements. The first element is proposed by the applicant and idongiva- breaks a couple of the rules. (1) It is too long, and (2) it clearly is intended to have meaning (you will never see a drug called, e.g., amazumab). It probably complies with a third rule, that it is pronounceable in the major languages, and possibly complies with another, that it cannot be confused in writing and speech with the name of another existing drug. The second and subsequent stems are assigned based on the chemical and medical categories that the drug falls into. New stems are invented when new categories are discovered, and sometimes a company with a borderline drug will apply for a new category so that their name is less similar to competitors… sometimes it works and sometimes it doesn't.

    The trade names are assigned as part of the package approving the drug for sale, by the EU's EMA, US's FDA, Japan's PMDA, etc. The whole of the name is proposed by the applicant, and there are similar rules to the generic names: it can't imply meaning and it can't be confused for another drug name. If you are interested then the FDA publish a Proprietary Name Review for all new approved drugs, which is sometimes really interesting. You can search their database here https://www.accessdata.fda.gov/scripts/cder/daf/ and find new drugs here https://www.fda.gov/drugs/development-approval-process-drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products.

    Finally a few technical notes. The generic name is conventionally written with a lower-case initial, while the trade name is capitalised. After the opening sentence, a typical FDA press release would refer to the drug by the trade name (Peaceaudi) not the generic name. Since 2017 the FDA has required biologics (which a mab is) to be marketed with an arbitrary four-letter suffix appended to the generic name (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-guidance-industry). The suffix is different for each manufacturer (and maybe each manufacturing site, and I think changes with a changed process), and recognises that unlike for small molecules biologics can have subtle variations based on their source.

    Sorry for the long post! I'm a professional observer of the pharmaceutical industry with a personal and professional interest in chemical nomenclature.

  5. mae said,

    August 2, 2019 @ 7:55 am

    @viseguy: Esso paid a lot: "Exxon came from 10,000 names dredged up by a computer – to then be studied by lawyers, linguistic experts and other specialists. The idea was to make sure the new name would have no adverse connotations in any of the multitude of languages the company dealt in, and preferably no meaning at all. The name change cost more than $100 million."

    Of course soon after that came the Exxon Valdez oil spill, and the name Exxon took on adverse connotations in ALL languages.

    Source: https://www.nytimes.com/1982/05/09/business/the-singular-power-of-a-giant-called-exxon.html

  6. Jonathan said,

    August 2, 2019 @ 9:49 am

    @Ursa Major: Great comment. Thanks.

  7. Mary Kuhner said,

    August 5, 2019 @ 2:46 pm

    Ursa Major, your post makes me wonder how bupropion got the trade name Wellbutrin, which seems like a clear violation of "cannot imply a meaning." I was surprised when I first encountered it, even though I didn't know the rules you stated; now it's even weirder.

    An unrelated but fun naming story: My spouse has rheumatoid arthritis and is taking tofacitinib/Xeljanz, which is a JAK inhibitor. JAK is "Janus kinase" but Wikipedia claims (and I find this totally believable) that the acronym originally meant "Just Another Kinase" as the lab in question had discovered quite a few!

    Is there a term for this phenomenon, when an acronym that originally referred to a frivolous name is back-constructed into a more reputable one? In roleplaying games it is often claimed (I don't know if it's true) that GURPS, the Generic Universal RolePlaying System, started its life as "Great Unnamed", and that TORG was "The Other Roleplaying Game."

    Naming is a tricky thing. If a gene is discovered in fruit flies, where the naming culture is rather consistently goofy, and then the same gene is found in humans, it ought to have the same name; but this conflicts with the desire of parents not to hear that their child is ill because of defects in "sonic hedgehog". (That gene is called SHH in humans, shush, don't ask what it stands for.) I could easily see this name getting re-acronymed as above.

  8. Ursa Major said,

    August 8, 2019 @ 5:11 am

    Mary, my guess would be that it is because bupropion is an old drug (Wellbutrin first approved in 1985, as far as I can see) and the FDA can't or won't force a name change to comply with new standards. I perhaps should have said "principles" instead of "rules". I'm not involved directly in the industry so don't know the details of the process and its requirements.

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