Biohaven Withdraws Dazluma Application

The agency’s main drug review committee said  it had some concerns about Dazluma, and its provisional opinion was a marketing authorization would not be granted. The committee explained that not only was Dazluma’s effectiveness not proven, but Biohaven had requested the drug receive a “new active substance” classification, which comes with significant commercial benefits. EMA staff were not convinced the drug is significantly different than plain riluzole. In an emailed statement, Biohaven CEO Vlad Coric said his company ultimately withdrawn the approval application once it became clear the committee did not intend on bestowing that classification.

 CEO Coric added that Biohaven is committed to quickly providing the committee with either further arguments, “appropriate data,” or both, and plans to do so in approximately three months. The company “remains committed to the Dazluma program and plans to resubmit to EMA this year once the data is generated to respond to” the new active substance issue