- The European Medicines Agency (EMA) validated to review AB Science's ( OTC:ABSCF ) application seeking conditional approval of Alsitek (masitinib) to treat amyotrophic lateral sclerosis (ALS).
- The French drugmaker said that the EMA's Committee for Medicinal Products for Human Use (CHMP) has begun reviewing its conditional marketing authorization application. The CHMP has a target of 210 active evaluation days to review the application.
- In 2018, the CHMP had declined to recommend the approval of Alsitek for ASL following which AB Science filed a request with the panel to re-examine the application. However, later this request was withdrawn by the company.
- AB Science said in an Aug. 24 press release that its application was backed by data from a phase 2/3 trial called AB10015, and its long-term survival follow-up.
- ALS is a progressive nervous system disorder affecting nerve cells in the brain and spinal cord, leading to loss of muscle control.
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AB Science's ALS drug Alsitek gets EMA review