Erytech has withdrawn an application for approval of its tumor starvation drug in Europe after the regulator demanded more data. Generating the data and preparing a fresh submission in acute lymphoblastic leukemia (ALL) will take until the middle of next year, a delay that prompted investors to drive down Erytech’s stock price by more than 20%.
Lyon, France-based Erytech said the Committee for Human Medicinal Products (CHMP) wants to see additional data comparing the old and new forms of the enzyme encapsulated in Graspa. CHMP has made further requests relating to an immunogenicity assay and the pharmacodynamic effects of the drug. Generating these data will take Erytech longer than is provided under the European Medicines Agency timelines, forcing it to pull the application it filed in September 2015.
“It is disappointing that assembling the data necessary to properly address the remaining questions is requiring longer time than we were actually granted at this stage,” Erytech CMO Iman El-Hariry said in a statement. “We are committed to pursuing regulatory approval for Graspa and intend to work closely with our investigators and advisors to generate the additional information requested and to resubmit [a marketing authorization application] next year.”
Investors responded by wiping 20% off Erytech’s share price in Paris. The latest slip means the stock has fallen more than 40% since investors first got wind that the filing could be heading toward a road block in September.
Erytech flagged up potential problems with the application after receiving preliminary feedback on its responses to CHMP’s day 120 list of questions. At that time, Erytech warned it may take longer than originally expected to address the outstanding issues, but said it still expected CHMP to rule on Graspa next year. Erytech reiterated the expectation earlier this month, at which time it had seen the list of outstanding issues that ultimately prompted it to pull the filling. The drug is now unlikely to come to market until the back end of 2018.