The Trogarzo IM sBLA submission follows the recent FDA approval of the Company's Labelling Prior Approval Supplement to include a 2,000-mg intravenous (IV) push loading dose, which can now be delivered in as little as 90 seconds and no longer requires treatment to be initiated in specialized infusion clinics. The potential addition of an entirely new method of administration for the maintenance dose via a rapid IM injection every two weeks could further simplify the Trogarzo treatment regimen.
'The intramuscular method of administration, if approved for the maintenance dose, will give patients and their health care providers more options for Trogarzo treatment and without the need for regular IV placement,' said
In accordance with the
About Trogarzo
Trogarzo (ibalizumab-uiyk) is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor. In
Trogarzo is administered by intravenous (IV) infusion as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP. The Trogarzo loading dose can also be administered as an undiluted IV push over 90 seconds, and the maintenance dose can be administered as an undiluted IV push over 30 seconds.
Important Safety Information
Do not receive Trogarzo if you have had an allergic reaction to Trogarzo or any of the ingredients in Trogarzo. Trogarzo can cause allergic reactions, including serious reactions, during and after infusion. Tell your healthcare provider or nurse, or get medical help right away if you experience any symptoms of an allergic reaction. Before you receive Trogarzo, tell your healthcare provider about all of your medical conditions, including if you are pregnant or plan to become pregnant as it is not known if Trogarzo may harm your unborn baby, or if you are breastfeeding or plan to breastfeed as it is not known if Trogarzo passes into breast milk. Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements.
Changes in your immune system (immune reconstitution inflammatory syndrome) can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine. The most common side effects of Trogarzo include diarrhea, dizziness, nausea, and rash. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Trogarzo. For more information, ask your healthcare provider or pharmacist.
Full prescribing information is available at www.trogarzo.com.
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 approval of the IM method of administration for the maintenance dose of Trogarzo by the FDA and the expansion of treatment options for heavily treatment-experienced adults with HIV. 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, the approval by the FDA of the IM method of administration for the maintenance dose of Trogarzo, if and when approved, and the market acceptance of the IM method of administration for the maintenance dose of Trogarzo. 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 non-approval by the FDA of the IM method of administration for the maintenance dose of Trogarzo, even if approved, lack of market acceptance of the IM method of administration for the maintenance dose of Trogarzo by patients and physicians, the difficulty in switching patients from the current method of administration of the loading dose to a new one, and the incapacity to grow sales of Trogarzo despite the introduction of this new method of administration. 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.
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