Mereo BioPharma: FDA Grants Fast Track Designation For Alvelestat - Quick Facts

(RTTNews) - Mereo BioPharma Group plc (MREO) announced the FDA has granted Fast Track designation for its investigational oral neutrophil elastase inhibitor, alvelestat. The company plans to have an end-of-phase 2 meeting with the FDA to discuss the design of a registration-enabling study for alvelestat as a treatment for AATD-associated lung disease, including the potential opportunity for an accelerated approval pathway, around the end of the year.

In May, the company reported positive top-line safety and efficacy data from the ASTRAEUS phase 2 study of alvelestat in severe AATD-associated emphysema. The company plans to provide a further update on the program on October 31, 2022.

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