- FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicity
- CRL does not impact commercial availability of EGRIFTA SV®, the F4 formulation of tesamorelin, the only medication approved in the
U.S. for the reduction of excess abdominal fat in adults with HIV and lipodystrophy
The questions outlined in the CRL are largely related to chemistry, manufacturing and controls (CMC) concerning the microbiology, assays, impurities and stability for both the lyophilized product and the final reconstituted drug product. In addition, the FDA requested further information to understand the potential impact of the proposed formulation on immunogenicity risk.
“While we are disappointed to receive a Complete Response Letter from the FDA for the F8 formulation of tesamorelin containing questions that were not raised during the review process, we plan to address these new comments as swiftly as possible,” said
The Company will continue to commercialize EGRIFTA SV®, which is the only approved treatment in the
About EGRIFTA SV® (tesamorelin for injection)
EGRIFTA SV® is approved in the
* 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 to 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
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 management’s beliefs and assumptions and on information currently available to it. 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 pursuit of the approval of the F8 formulation and the timelines associated with addressing the questions received from the FDA. 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 these statements since actual results may vary from the Forward-Looking Statements contained in this press release. These assumptions include, without limitation, that the Company will be able to satisfactorily address the questions raised by the FDA, resubmit the file to the FDA for approval and obtaining approval of the F8 formulation of tesamorelin. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s 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, the inability of the Company to properly address the concerns of the FDA, and, even if the concerns are addressed, the non-approval of the F8 formulation by the FDA because the Company’s responses are not to the satisfaction of the FDA. We refer current and potential investors to the “Risk Factors” section of our Annual Information Form dated
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:
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
Investor Inquiries:
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
438-315-6608
Source:
2024 GlobeNewswire, Inc., source