AB Science will not seek review of masitinib rejection in Europe

pharmafile | May 29, 2018 | News story | Manufacturing and Production, Sales and Marketing |  EMA, Europe, ab science, als, masitinib, pharma 

AB Science has U-turned on its pursuit of a do-over on its marketing application of masitinib in Europe after the drug was rejected in the treatment of amyotrophic lateral sclerosis (ALS) by the EMA’s Committee for Medicinal Products for Human Use in April this year.

In its review, the EMA said that the data supporting the application of masitinib was simply not robust enough, and additional evidence would be needed to awarded marketing authorisation. AB Science had responded with the promise of submitting this additional, necessary information.

However, the firm has now backed down on a review of the decision, noting: “AB Science determined that the re-examination procedure would not be the most appropriate format to address all the pending concerns raised by the Committee for Human Medicinal Products (CHMP). AB Science will discuss with EMA the pathway forward to seek marketing authorisation for the use of masitinib in the treatment of ALS.”

The company instead explained in a statement that the recent submission for masitinib could not include the final safety data for the drug, which were generated in February this year, confirming that it is now considering a resubmission which includes these data, as well as new sensitivity analyses of patients who ended the study prematurely and new preclinical data supporting the drug’s efficacy.

Matt Fellows