FDA Grants Fast Track Status To Telitacicept For Lupus

The United States Food and Drug Administration (FDA) has granted Fast Track designation for a new lupus treatment option. The drug, called telitacicept or RC18, is an entirely new drug type for lupus. Telitacicept is still in clinical trials, however, the FDA has determined that it is showing great promise.

By granting Fast Track designation to the drug, it allows the development and approval processes to go quicker for the drug’s manufacturer, RemeGen Ltd. This will help telitacicept move more swiftly through the hurdles required of a new drug. It also means the FDA will be more accessible to answer questions as they arise. All of these factors help promising drugs get on the market and to the people who need them as fast as possible.1

How does telitacicept work?

Telitacicept is a new type of drug. It is a recombinant fusion protein, meaning it combines different protein types that have different interactions in the body. Telitacicept is a transmembrane activator and calcium modulator and cyclophilin ligand interactor fusion protein (TACI-Fc). Although this title is long, the way the drug acts in the body is very specific. Telitacicept targets mature B cells and plasma cells. B cells and plasma cells make antibodies. In certain autoimmune conditions, like lupus, it is thought that these antibodies are unusual, leading to a faulty immune response.

Telitacicept interferes with the way these antibody-making cells communicate with other signals in the body. It targets specific growth signals called BLyS (B lymphocyte stimulator) and APRIL (a proliferation-inducing ligand). By blocking these signals, antibody-making cells cannot survive. This may slow down or stop the faulty immune response in conditions like lupus.1-3

Telitacicept in clinical trials

Telitacicept is currently being investigated in Phase 3 trials for lupus. These late-stage trials will hopefully provide the information needed to determine if the drug will be on the market soon. In addition to lupus, telitacicept is also being studied for the treatment of rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, neuromyelitis optica spectrum disorder (NMOSD), and more.

Results from a Phase 2b clinical trial were released in 2019, and showed that telitacicept had potential benefits for those with lupus. The trial compared telitacicept and placebo in combination with standard therapy. The safety and efficacy of telitacicept was evaluated at the 48-week mark. Different dosages of telitacicept were used, and all treatments were given once a week. The researchers used the SLE Responder Index 4, a scale used to measure lupus activity and response to treatment. Some of the factors it considers are flare rate, need for steroid treatment, and skin rashes.

Overall, over 75 percent of those taking the highest dose of telitacicept experienced a clinically meaningful improvement in their lupus. In comparison, only 34 percent of those taking placebo reached this mark. While the highest percentage of those experiencing improvements in their lupus were taking the largest dose of the new drug, those taking smaller doses of telitacicept also experienced a greater improvement when compared to placebo.3

What are the side effects of telitacicept?

While more research is needed to determine the side effects of telitacicept, the most common events experienced in clinical trials so far are injection site reactions and upper respiratory infections.3

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