Drug news: Setback for Rejena
According to a Reuters report the FDA is not ready to give the thumbs up to River Plate/Alcon's sodium hyaluronate drop "Rejena", which is already on the market in Europe.
FDA reviewers, in a separate analysis prepared for the meeting, said they had identified "three major statistical
issues" in River Plate's application to market a hyaluronate sodium solution under the name Rejena.
One of the company's key studies lacked a "robust treatment effect" for the product, the reviewers said. An earlier study
failed to meet its main goal to show effectiveness and an FDA reviewer could not replicate the company's finding that secondary goals were met, the FDA staff said....
UBS analyst Marc Goodman, in a research note, said there was a "strong likelihood" the FDA panel would recommend against
approval of the River Plate drug and might urge additional studies.