FDA Approves Novel Single-Vial Formulation of EGRIFTA®
MONTREAL, Nov. 05, 2018 (GLOBE NEWSWIRE) — Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that the Food and Drug Administration in the United States has approved the new single-vial formulation of EGRIFTA® (tesamorelin for injection). EGRIFTA® is a growth hormone-releasing factor analog and is the only FDA-approved treatment for excess abdominal visceral adipose tissue (VAT) in HIV-infected patients with lipodystrophy.
The novel formulation, currently known as “F4”, is indicated for the reduction of excess abdominal fat in HIV infected patients with lipodystrophy which is the same indication as the original two-vial formulation of EGRIFTA® approved by the FDA.
Lipodystrophy is a serious metabolic condition which is associated with the development of insulin resistance, diabetes, fatty liver and high triglyceride level.
The new single-vial formulation is four times more concentrated than the currently commercialized formulation of EGRIFTA®. As a result, it reduces the volume of administration to 0.35 ml instead of 2.0 ml for the current formulation. Its handling is also more user-friendly as it comes in a single vial instead of two. Furthermore, it is stable at room temperature, thus it does not require a cold-chain distribution network from the manufacture to the patient. This represents an advantage for patients as well as for Theratechnologies.
“At this stage of the product’s lifecycle, the new formulation represents a tremendous opportunity to revitalize the brand. The launch of the new formulation will help to re-energize this important product for Theratechnologies and help patients manage a serious HIV co-morbidity,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
“The new formulation offers several advantages over the currently marketed two-vial formulation. This will definitely help to support growth in the coming months and years,” added Mr. Tanguay.
EGRIFTA® is currently approved in the United States, Canada and Mexico.
You should not take EGRIFTA® if you
- have or have ever had any problems with your pituitary gland.
- have cancer or are receiving treatment for cancer.
- are allergic to tesamorelin or any of the ingredients in EGRIFTA®.
- are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA® and talk with your healthcare provider.
- are less than 18 years of age.
The most common side effects of EGRIFTA® include: joint pain, pain in legs and arms, swelling in your legs, muscle pain, tingling, numbness and pricking, nausea, vomiting. For more information on EGRIFTA®, please visit www.egrifta.com.
Full prescribing information available at www.egrifta.com
Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs by bringing to market specialized therapies for people with orphan medical conditions, including those living with HIV. Further information about Theratechnologies is available on the Company’s website at www.theratech.com and on SEDAR at www.sedar.com.
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “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, sales growth of EGRIFTA® and the positive receipt by patients and physicians of this new formulation.
Forward-looking statements are based upon a number of assumptions and 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 information. These assumptions include but are not limited to, the following: patients and physicians will welcome such new formulation, leading to increased sales of EGRIFTA®.
These risks and uncertainties include, but are not limited to, the risk that EGRIFTA® growth is not supported with the introduction of the F4 formulation.
We refer potential investors to the “Risk Factors” section of our Annual Information Form dated February 6, 2018 available on SEDAR at www.sedar.com for additional risks and uncertainties about Theratechnologies and its 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.
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