When was Soliris approved by the FDA?

Written by Inês Martins, PhD | April 18, 2023

When was Soliris approved by the FDA?

Category: Soliris

The U.S. Food and Drug Administration (FDA) initially approved Soliris in 2017 to treat adults with generalized myasthenia gravis (gMG) who are positive for antibodies against the acetylcholine receptor (AChR). That marked the first approval for the disease in the U.S. in more than 60 years. In 2025, the FDA approved a label expansion, extending the use of Soliris to children with AChR-positive gMG, ages 6 and older. This made Soliris the first and only therapy to be approved for pediatric gMG patients in the U.S.

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About the Author

Inês Martins, PhD Inês holds a PhD in biomedical sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied cell and molecular biology at Universidade Nova de Lisboa and worked as a research fellow at several research institutes. In addition to several college awards, Inês won the Pfizer Basic Research Award in 2012 for a research paper. Motivated by a desire to make complex scientific information accessible to those who need it most, Inês joined Bionews in 2016 as a science writer. She later became a managing science editor and now serves as the editorial associate director of science, helping lead a team of writers and editors dedicated to providing accurate, clear, and empowering information to the rare disease community.