Regulatory Affairs

AB Science plans to resubmit marketing application in Europe for ALS treatment masitinib

PBR Staff Writer Published 29 May 2018

AB Science is evaluating options to resubmit the marketing authorization application (MAA) in Europe for its amyotrophic lateral sclerosis treatment (ALS), masitinib.

The company decided to not to pursue the re-examination procedure, which the firm initially requested for the MAA of masitinib in the treatment of ALS.

The firm has determined that the re-examination procedure is not an appropriate format to address all the pending concerns raised by the Committee for Human Medicinal Products (CHMP).

AB Science will negotiate with EMA about the pathway to be followed to secure marketing authorization for the use of masitinib in the treatment of ALS.

In September 2016, the company filed MAA to the EU, based on the interim results from study AB10015.

In February this year, the final safety data has been generated, which could not be inspected during the evaluation. As part of a reexamination procedure, the company will not present the new data.

The company is assessing the possibility to resubmit the application based on the final results from study AB10015.

As part of the resubmission, AB Science is planning to submit final safety data, new sensitivity analyses on the primary analysis of the ALSFRS-R score for patients who stopped the study prematurely and new preclinical data reinforcing the mechanisms of action of masitinib.

Amyotrophic lateral sclerosis is a rare degenerative disorder, which could result in wasting and progressive paralysis of muscles.

Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages via inhibiting a limited number of kinases.

Based on its mechanism of action, masitinib can be developed to treat multiple conditions in oncology, inflammatory diseases and certain diseases of the central nervous system.

Established in 2001, AB Science is engaged in the research, development and commercialization of protein kinase inhibitors (PKIs), a  class of targeted proteins whose action are key in signaling pathways within cells.