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#1 Dec. 5, 2019 09:20:26

Kimberly
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(UPDATED 12/13/19) Teprotumumab - Results from FDA Advisory Committee Meeting in Silver Spring, MD

On Friday, Dec. 13th, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee will meet in Silver Spring, MD to discuss teprotumumab, a potential treatment for active thyroid eye disease.

If you are interested in attending in person or submitting a comment to the FDA, please see the link below for details.

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.

https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-public-participation-information-december-13-2019-meeting-dermatologic-and-ophthalmic-drugs


Kimberly
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…through nature's inflexible grace, I'm learning to live…
– Dream Theater

Edited Kimberly (Dec. 13, 2019 16:07:21)

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#2 Dec. 13, 2019 16:06:04

Kimberly
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(UPDATED 12/13/19) Teprotumumab - Results from FDA Advisory Committee Meeting in Silver Spring, MD

UPDATE: The Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA voted 12-0 Friday in favor of recommending approval of a biologics license application for teprotumumab, a potential new treatment for active thyroid eye disease. 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.

* Comittee 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 at Endocrine Today: https://www.healio.com/endocrinology/thyroid/news/online/%7Bb02b4c4e-6f26-42bc-8267-74c2021b12dd%7D/fda-committee-unanimously-recommends-approval-of-teprotumumab-for-thyroid-eye-disease


Kimberly
GDATF Forum Facilitator

…through nature's inflexible grace, I'm learning to live…
– Dream Theater

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