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Treatment Action Group's Statement on U.S. FDA Approval of Pretomanid

By Erica Lessem | 14 Aug, 2019

*apologies for cross-posting*


*Statement from Treatment Action Group on U.S. FDA Approval of Pretomanid *

*TAG welcomes simpler, shorter treatment options for people with some forms
of drug-resistant tuberculosis, while urging additional research and
equitable access*

*August 14, 2019* — Treatment Action Group (TAG) welcomes the advent of
shorter, simpler treatment for the most difficult to treat forms of
drug-resistant tuberculosis (DR-TB). As only the second new TB drug to *receive
U.S. Food and Drug Administration (FDA) approval
in the past two decades, pretomanid—which was approved for extensively and
pre-extensively or treatment intolerant DR-TB, in combination with
bedaquiline and linezolid—represents a milestone in TB treatment

However, given the limited evidence supporting the drug’s contribution to
the regimen—in contrast to the other two drugs, whose potency against TB
are relatively well-characterized—and the small and uncontrolled design of
the trial on which the FDA’s decision was based, many questions remain
about pretomanid and of the bedaquiline-linezolid-pretomanid regimen
(referred to as the Nix-TB regimen or BPaL). TAG is especially concerned
about how this approval has the potential to reduce regulatory standards
for the development of future TB drugs and regimens intended to optimize
the safety, duration, and efficacy of treatment regimens for DR-TB. These
questions and concerns are elaborated in *TAG’s testimony
to the FDA Antimicrobial Drugs Advisory Committee,[1]
<#m_3726628688034328802_m_4679998468509814523__ftn1> and the *Global TB
Community Advisory Board’s research, regulatory, and access considerations
regarding pretomanid
.[2] <#m_3726628688034328802_m_4679998468509814523__ftn2> TAG has also
shared with the FDA our broader c*oncerns about lowering the evidentiary
bar for approval with the Limited Population Pathway for Antibacterial and
Antifungal Drugs*
;[3] <#m_3726628688034328802_m_4679998468509814523__ftn3> pretomanid is the
second drug approved under this new pathway.

“Many people with extensively or pre-extensively drug-resistant TB would
welcome a three-drug, all-oral, six-month regimen with a high cure rates,
and therefore would want the option to access pretomanid, along with
bedaquiline and linezolid,” said Mark Harrington, TAG’s executive director.
“However, we support remarks by members of the FDA Antimicrobial Drugs
Advisory Committee that pretomanid’s approval should not be
precedent-setting in terms of the small sample size and non-controlled
design of its pivotal clinical trial, Nix-TB. Robust development programs
based on randomized controlled trials must continue to be the required bar
for new drug and regimen approval, even and especially for the world’s
deadliest infectious disease, to ensure that those with TB receive
treatment that meets the highest scientific standards for safety and

Many important questions also remain about the specifics of the non-profit
TB Alliance’s oft-stated “Adoption, Availability, and Affordability” policy,
[4] <#m_3726628688034328802_m_4679998468509814523__ftn4> especially in
light of a non-transparent, license of pretomanid to the for-profit generic
manufacturer Mylan. “Equitable access to TB medicines is a human right. As
the developer of the third new drug for DR-TB in the past six years, TB
Alliance should learn from both the positive examples and mistakes of
Janssen and Otsuka’s introductions of bedaquiline and delamanid,
respectively,” noted Lindsay McKenna, TAG’s TB project co-director.
“Philanthropic and public funding underpinned pretomanid’s development; it
must be treated as a public good. This means at a minimum: full
transparency, broad registration, pre-approval access, and a low global
price of $1/day, in keeping with research on cost of goods and calls for a
$500 DR-TB regiment.[5] <#m_3726628688034328802_m_4679998468509814523__ftn5>
,[6] <#m_3726628688034328802_m_4679998468509814523__ftn6>”


*About TAG*: Treatment Action Group (TAG) is an independent, activist and
community-based research and policy think tank fighting for better
treatment, prevention, a vaccine, and a cure for HIV, tuberculosis, and
hepatitis C virus. TAG works to ensure that all people with HIV, TB, or HCV
receive lifesaving treatment, care, and information. We are science-based
treatment activists working to expand and accelerate vital research and
effective community engagement with research and policy institutions. TAG
catalyzes open collective action by all affected communities, scientists,
and policy makers to end HIV, TB, and HCV.

[1] <#m_3726628688034328802_m_4679998468509814523__ftnref1> TAG. Testimony
to the FDA on New Drug Application for Pretomanid Tablets. Jun 6, 2019.

[2] <#m_3726628688034328802_m_4679998468509814523__ftnref2> Global TB
Community Advisory Board. Research, Regulatory, and Access Considerations

Pretomanid. May 15, 2019.

[3] <#m_3726628688034328802_m_4679998468509814523__ftnref3> TAG. Oral
comment re: docket number FDA-2018-D-2032 Public Meeting on Limited
Population Pathway for Antibacterial and Antifungal Drugs. July 12, 2019.

[4] <#m_3726628688034328802_m_4679998468509814523__ftnref4> TB Alliance.
Our Commitment. https://www.tballiance.org/access/our-commitment

[5] <#m_3726628688034328802_m_4679998468509814523__ftnref5> Gotham D,
Fortunak J, Pozniak A, et al. Estimated generic prices for novel treatments
for drug-resistant tuberculosis. J Antimicrob Chemother. 2017 Apr 1; 72(4):
1243-1252. doi: 10.1093/jac/dkw522.

[6] <#m_3726628688034328802_m_4679998468509814523__ftnref6> Médecins Sans
Frontières. Developing countries hit with high price for important new
tuberculosis drug. 24 February 2016.

*Contact Us:* Treatment Action Group, 90 Broad Street, Suite 2503, New
York, New York 10004, 212-253-7922.
TAG fights for life-saving medications for people living with, and at risk
for, HIV, TB, and HCV. Please consider supporting this work by making a a



Abdul ghafoor Replied at 1:31 AM, 15 Aug 2019

Thanks Erica for sharing very useful and informative statement.

SOPHAN SAM Replied at 2:56 AM, 15 Aug 2019

Thank for sharing the approved new drug for more option to treat MDRTB

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