Vertex Pharmaceuticals said it completed the submission to the U.S. Food and Drug Administration of its rolling Biologics Licensing Application for potential accelerated approval of povetacicept for the treatment of immunoglobulin A nephropathy in adults.

1. 01

   Vertex Pharmaceuticals said it completed the submission to the U.S. Food and Drug Administration of its rolling Biologics Licensing Application for potential accelerated approval of povetacicept for the treatment of immunoglobulin A nephropathy in adults.

2. 02

   The company said it used a priority review voucher. It explained that as a result, the FDA's review of the povetacicept BLA is expected to be expedited to 6 months from the date of the FDA's acceptance of the BLA.

3. 03

   Vertex Pharmaceuticals said that with the use of a priority review voucher, the FDA review period is expected to proceed for six months from the date of the FDA's acceptance of the BLA, versus the typical ten-month review.

4. 04

   The company said its forward-looking statements in this disclosure include the expected duration of the FDA review and the potential for accelerated approval, and that there are risks that regulatory approval may not be obtained or approval may be delayed.

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Original filing

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