TGTX - TG Therapeutics Awarded National Contract by the Department of Veterans Affairs for BRIUMVI as the Preferred Anti-CD20 for Relapsing Forms of Multiple Sclerosis | Benzinga
NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), announced that it has been awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI® (ublituximab-xiiy) to be the preferred agent listed on the VA National Formulary for Anti-CD20 Antibody indications for patients with relapsing forms of multiple sclerosis (RMS).
Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, "We are immensely proud to collaborate with the National VA Health System in bringing BRIUMVI to Veterans across the country afflicted with RMS at a significant discount. We believe this contract signifies a vote of confidence in the value that BRIUMVI brings to patients with RMS and are pleased that Veterans with MS will now have access to the only anti-CD20 therapy that offers a one-hour twice a year therapy, following the first dose."
The contract period includes the base year ordering period of June 17, 2024 to June 16, 2025, as well as four one-year option periods that may be exercised unilaterally by the U.S. Government. Pursuant to the contract, BRIUMVI will be required for new patient starts unless clinically contraindicated. While not required, patients currently prescribed other agents in the anti-CD20 class may be switched over to BRIUMVI at the discretion of their doctor. The total award amount of the contract has a potential value of $186,776,520. This potential value assumes all MS patients estimated to be treated with anti-CD20 therapies by the VA annually, are treated with BRIUMVI each year for a five-year period at the contract price.
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
A list of authorized specialty distributors can be found at www.briumvi.com.
IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.
Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.
Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation ...