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February 18, 2021

LoA Update: Evolve’s Phase III PlasmaCap IG for PIDD sees 11-point boost to FDA regulatory potential

As of 11 February, the likelihood of approval (LoA) for Evolve Biologic’s Phase III PlasmaCap IG (immune globulin) for primary immune deficiency disease (PIDD) rose 11 points, according to GlobalData’s LoA data.

By William Newton

As of 11 February, the likelihood of approval (LoA) for Evolve Biologic’s Phase III PlasmaCap IG (immune globulin) for primary immune deficiency disease (PIDD) rose 11 points, according to GlobalData’s LoA data. The score was based on a company announcement that immune globulin reached all of its primary and secondary endpoints.

On 9 February, the Ontario, Canada-based Evolve announced that the 74-patient Phase III met its primary endpoint of achieving mean annual acute serious bacterial rate for immune globulin statistically significantly lower than one infection per year. In addition, 97% of all treatment emergent adverse events (TEAEs) were mild or moderate, with the most common TEAEs being headache, fatigue and nausea, the company press release said.

While the LoA prior to this news was 33%, GlobalData’s analysis using a combination of machine learning and a proprietary algorithm has raised the LoA to 44%. Evolve will present an abstract on trial results in April at the Clinical Immunology Society meeting. The company’s first commercial facility is in early development, and Evolve plans to submit a BLA for immune globulin to the FDA after completion.

William Newton is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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