麻豆传媒

The on Tuesday for adults with thyroid eye disease, making it the only non-surgical, FDA-approved treatment for this potentially blinding condition.

Teprotumumab is a fully human monoclonal antibody inhibitor of insulin-like growth factor-1 receptor and is administered in eight doses, given as 30- to 90-minute infusion once every 3 weeks.

The FDA greenlight was not a surprise, after an FDA advisory committee unanimously voted (12-0) in favor of teprotumumab's approval last month.

The treatment is supported by the positive phase II and phase III OPTIC findings, the latter of which was presented at the 2019 American Association of Clinical Endocrinologists (AACE) meeting. After 24 weeks of teprotumumab infusions, patients with active thyroid eye disease saw an average 2.82 mm reduction in proptosis, otherwise known as bulging of the eyes.

Other benefits included an improvement in double vision and clinical activity score.

The most common adverse events with teprotumumab in the OPTIC trials included muscle spasms, nausea, alopecia, and diarrhea. The label will carry a warning about the risk for a potential exacerbation of preexisting inflammatory bowel disease and hyperglycemia.

it has plans for a post-marketing study to follow these potential risks and to assess retreatment rates.

"I think it's kind of a watershed moment in how we'll look at the treatment of this disease -- before and after the advent of teprotumumab," lead investigator Raymond Douglas, MD, PhD, of Cedars Sinai Medical Center in Los Angeles, told 麻豆传媒 at the AACE meeting. "I think one of the exciting aspects is that, this drug, the effect, is relatively similar to what I'm achieving with surgery."

"And so I think that kind of the ultimate underlying and main message is that the result that you're seeing here [with teprotumumab] is really significant, and clinically significant. That's the exciting part for both patients and treating physicians because that's never been seen in any other drug," Douglas added.

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