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On Friday, Dec. 13th, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee met in Silver Spring, MD to discuss teprotumumab, a potential treatment for active thyroid eye disease.
The committee voted 12-0 Friday in favor of recommending approval of a biologics license application for teprotumumab. This is not the final approval, but is one step in the process. Key takeaways:
* Committee members expressed concern about the small study population (90 patients).
* Side effects were discussed (gastrointestinal disorders, infections, muscle spasms, hyperglycemia, and reproductive system and breast disorders), and committee members expressed particular concern about reports of hearing loss and the need for glucose monitoring.
* Committee Chair James Chodosh, MD, MPH, D.G. Cogan professor of ophthalmology at Harvard Medical School, associate director of cornea service at Massachusetts Eye and Ear noted, “I don’t say this about every disease, but I hate this disease...it is a devastating problem for patients. This is a disease that we need to do something for. This is a bad disease, and it has a tremendous impact on people’s lives. Though the numbers were small, the data presented was quite remarkable for a clinical trial.”
For additional details, please see this link from Regina Schaffer.
The FDA's Advisory Committees provide independent advice from outside experts on issues related to human and veterinary drugs, biological products, medical devices, and food.