Vertex: FDA Lifts Clinical Hold on VX-880 Study in Type 1 Diabetes

By Colin Kellaher

Vertex Pharmaceuticals Inc. on Tuesday said the U.S. Food and Drug Administration has lifted a clinical hold the agency had placed on a Phase 1/2 study of VX-880 in type 1 diabetes.

The Boston drug maker, which is studying VX-880 as an insulin-producing islet cell therapy in people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia, said it will reopen the trial for screening, enrollment and dosing at multiple sites in the U.S.

Vertex in early May said the FDA placed the study on clinical hold after determining there was insufficient information to support dose escalation with the product.

The company said at the time that it was surprised by action, and that it planned to work with the FDA to address the agency's questions in a bid to resume the study as soon as possible.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 05, 2022 08:30 ET (12:30 GMT)

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