Theratechnologies Receives January 2024 PDUFA Goal Date for Tesamorelin F8 Formulation sBLA
04 Oktober 2023 - 1:30PM
Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX:
TH) (NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, today
announced that the U.S. Food and Drug Administration (FDA) has
assigned a Prescription Drug User Fee Act (PDUFA) goal date of
January 22, 2024 to the Company’s supplemental Biologics License
Application (sBLA) of the F8 formulation of tesamorelin.
Tesamorelin is the only medication approved in
the U.S. for the reduction of excess abdominal fat in adults with
HIV who have lipodystrophy. Once approved, the F8 formulation is
set to replace the current F4 formulation, which is sold in the
U.S. under the trade name EGRIFTA SV®. The proposed proprietary
name for the F8 formulation of tesamorelin, EGRIFTA MDVTM, is
already under review by the FDA.
In accordance with the FDA’s standard review
practices, unless the Company is notified before November 21, 2023,
that the application is not sufficiently complete to permit a
substantive review, the FDA will file the sBLA for the F8
formulation of tesamorelin.
About EGRIFTA
SV® (tesamorelin for
injection)
EGRIFTA SV® is approved in the U.S. for the
reduction of excess abdominal fat in HIV-infected adult patients
with lipodystrophy*. EGRIFTA SV® is a growth hormone
releasing factor (GHRF) analog that acts on pituitary cells in the
brain to stimulate the production and release of endogenous growth
hormone.
* Limitations of Use:
- Long-term cardiovascular safety
of EGRIFTA SV® has not been established. Consider
risk/benefit of continuation of treatment in patients who have not
had a reduction in visceral adipose tissue.
- EGRIFTA SV® is not indicated
for weight loss management as it has a weight neutral effect.
- There are no data to support
improved compliance with anti-retroviral therapies in HIV-positive
patients taking EGRIFTA SV®.
Do not use EGRIFTA SV® if a
patient:
- Has a pituitary gland tumor, has
had pituitary gland surgery, has other problems related to their
pituitary gland, or has had radiation treatment to their head or
head trauma.
-
Has active cancer.
-
Is allergic to tesamorelin or any of the ingredients
in EGRIFTA SV®.
-
Is pregnant or planning to become pregnant.
The most commonly reported adverse reactions
of EGRIFTA SV® include: hypersensitivity reactions,
hyperglycemia, injection site reactions, arthralgia, pain in
extremity, myalgia and peripheral edema.
Refer to www.egriftasv.com for the
full prescribing information, patient information and instructions
for use for further details about this product.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a
biopharmaceutical company focused on the development and
commercialization of innovative therapies addressing unmet medical
needs. Further information about Theratechnologies is available on
the Company's website at www.theratech.com, on SEDAR
at www.sedarplus.ca and on EDGAR at www.sec.gov.
Follow Theratechnologies
on Linkedin and Twitter.
Forward-Looking Information
This press release contains forward-looking
statements and forward-looking information (collectively, the
“Forward-Looking Statements”), within the meaning of applicable
securities laws, that are based on our management’s beliefs and
assumptions and on information currently available to our
management. You can identify Forward-Looking Statements by terms
such as "may", "will", "should", "could", “promising”, “would”,
"outlook", "believe", "plan", "envisage", "anticipate", "expect"
and "estimate", or the negatives of these terms, or variations of
them. The Forward-Looking Statements contained in this press
release include, but are not limited to, statements regarding the
approval and filing of the F8 formulation by the FDA and its
proposed trade name, EGRIFTA MDVTM, and the exact user fee goal
date. Although the Forward-Looking Statements contained in this
press release are based upon what the Company believes are
reasonable assumptions in light of the information currently
available, investors are cautioned against placing undue reliance
on this information since actual results may vary from the
Forward-Looking Statements. Certain assumptions made in preparing
the Forward-Looking Statements include that: the FDA will file the
F8 formulation the user fee goal date will remain on January 22,
2024. Forward-Looking Statements are subject to a number of risks
and uncertainties, many of which are beyond Theratechnologies’
control that could cause actual results to differ materially from
those that are disclosed in or implied by such Forward-Looking
Statements. These risks and uncertainties include, but are not
limited to, those related to or arising from: a delay in the filing
of the sBLA for the F8 formulation, the postponement of the user
fee goal date, a rejection of the sBLA by the FDA because it deems
that the submission does not contain all of the prescribed
information, and the non-approval of the F8 formulation by the FDA
preventing its commercial launch in the United States. We refer
current and potential investors to the “Risk Factors” section of
our Annual Information Form dated February 27, 2023, available on
SEDAR at www.sedarplus.ca and on EDGAR
at www.sec.gov as an exhibit to our report on Form 40-F
dated February 28, 2023, under Theratechnologies’ public filings
for additional risks involved in our business. The reader is
cautioned to consider these and other risks and uncertainties
carefully and not to put undue reliance on Forward-Looking
Statements. Forward-Looking Statements reflect current expectations
regarding future events and speak only as of the date of this press
release and represent our expectations as of that date. We
undertake no obligation to update or revise the information
contained in this press release, whether as a result of new
information, future events or circumstances or otherwise, except as
may be required by applicable law.
Contacts:
Media inquiries:Julie SchneidermanSenior Director,
Communications & Corporate
Affairscommunications@theratech.com514-336-7800
Investor Inquiries:Philippe DubucSenior Vice President and Chief
Financial Officerpdubuc@theratech.com438-315-6608
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