Leqembi, also known as inebilizumab, is a medication that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). This rare autoimmune disease affects the central nervous system and can cause blindness, paralysis, and even death. Leqembi has been shown to be effective in reducing the frequency of NMOSD attacks, but a recent FDA panel has raised concerns about its safe use in the real world.
The FDA panel reviewed data from clinical trials of Leqembi and found that while it was effective in reducing NMOSD attacks, there were also some serious safety concerns. The panel noted that Leqembi can increase the risk of infections, including serious and potentially life-threatening infections such as pneumonia and sepsis. In addition, Leqembi can also cause infusion reactions, which can range from mild to severe and can include symptoms such as fever, chills, and difficulty breathing.
The panel also expressed concern about the lack of long-term safety data for Leqembi. While the clinical trials showed that Leqembi was effective in reducing NMOSD attacks over a period of two years, there is limited data on its safety beyond that time frame. The panel recommended that further studies be conducted to assess the long-term safety of Leqembi.
Despite these concerns, the panel acknowledged that Leqembi does provide clear benefits for patients with NMOSD. The medication has been shown to reduce the frequency of attacks and improve quality of life for patients. The panel recommended that Leqembi be made available to patients with NMOSD who have not responded to other treatments or who are unable to tolerate other treatments.
The FDA will now consider the panel’s recommendations and make a final decision on the use of Leqembi for the treatment of NMOSD. In the meantime, healthcare providers and patients should be aware of the potential risks associated with Leqembi and take appropriate precautions to minimize those risks.
In conclusion, Leqembi is a medication that has been shown to be effective in reducing NMOSD attacks, but there are also some serious safety concerns associated with its use. The FDA panel has recommended that further studies be conducted to assess the long-term safety of Leqembi, but also acknowledged that the medication provides clear benefits for patients with NMOSD. Healthcare providers and patients should be aware of the potential risks associated with Leqembi and take appropriate precautions to minimize those risks.
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- Source: Plato Data Intelligence.