Protalix Receives Complete Response Letter for Gaucher Disease Candidate

Protalix Biotherapeutics has received a complete response letter (CRL) from the FDA for its Gaucher disease candidate taliglucerase alfa, though the agency is not requiring additional clinical trials. The FDA’s CRL, received Friday, raised questions mainly related to clinical trials and chemistry, manufacturing and controls, the company said Friday. The agency also requested more information regarding testing specifications and assay validation as well as additional data from the company’s switchover trial and long-term extension trial. When the Israeli biotech submitted the NDA, full data from these trials was not yet available.
Drug Industry Daily