[Ip-health] KEI Submission to WHO Essential Medicines List – Enzalutamide / Abiraterone Acetate

Claire Cassedy claire.cassedy at keionline.org
Thu Feb 14 08:39:55 PST 2019


KEI Submission to WHO Essential Medicines List – Enzalutamide / Abiraterone

Posted on February 14, 2019 by Claire Cassedy

The WHO Essential Medicines List is a major WHO tool used to expand access
to medicines.  In 2017, the WHO issued the 20th Essential Medicines List
(EML) which was the 40th anniversary of the list.  The WHO is currently in
the process of making selections for it 22nd EML.  Interested parties file
applications for treatments that they believe should be included on the
EML. For more information on the list and the selection process, please
visit: https://www.who.int/selection_medicines/en/

KEI has previously filed applications for trastuzumab[1], trastuzumab
emtansine[2] (T-DM1), and enzalutamide[3]. Trastuzumab was added to the
19th EML[4] in 2015, while enzalutamide and T-DM1 were not included in the
20th EML (the cycle to which they were submitted).

This year, KEI submitted an application for enzalutamide and abiraterone
acetate[5], both important treatments for prostate cancer. The summary of
the application follows below.


Summary statement of the proposal for inclusion

Enzalutamide (sold by Astellas trade name Xtandi, sold by Glenmark trade
name Glenza) is indicated to treat metastatic castration-resistant prostate
cancer (CRPC) and is a second generation competitive androgen receptor
inhibitor. While there are other treatments used to treat CRPC,
enzalutamide is far less invasive as it is administered via daily oral
tablets, and has a low pill burden compared to the one other oral tablet
CRPC treatment (abiraterone acetate).

The first registration was by Astellas, for Xtandi. The patent protection
for Xtandi varies from country to country. At least one generic supplier,
Glenmark, has entered the market.

With recent clinical trials reporting better prostate cancer control when
enzalutamide is used in chemotherapy naive CRPC cases or in combination
with other agents, it is expected that this drug will soon be prescribed to
an even wider subset of patients. The listing of enzalutamide is being
sought for the core Essential medicines List.

Abiraterone acetate (sold by Johnson and Johnson under the trade name
Zytiga), is an antiandrogen medication which is used in the treatment of
prostate cancer. It is specifically indicated for use in conjunction with
castration and prednisone for the treatment of metastatic
castration-resistant prostate cancer (mCRPC) and in the treatment of
metastatic high-risk castration-sensitive prostate cancer (mCSPC).

The US patent 8,822,438, which covered Zytiga, was invalidated in October
2018.1 There several generic suppliers of abiraterone acetate.

Both drugs offer significant medical benefits for target populations,
although for some patients, one will better tolerated with few adverse
effects than the other.

[1] https://www.keionline.org/22582
[4] https://www.keionline.org/22756

Claire Cassedy
Knowledge Ecology International
1621 Connecticut Avenue NW
Suite 500
Washington, DC 20009
Tel.: 1.202.332.2670

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