CHMP rejects AB Science’s ALS therapy in Europe
pharmafile | April 23, 2018 | News story | Sales and Marketing | AB Sciences, EMA, European Medicines Agency, ab science, als, masitinib, pharma
AB Science has revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion of its oral tyrosine kinase inhibitor masitinib in the treatment of amyotrophic lateral sclerosis (ALS) in adults, damaging the drug’s chances of reaching market in Europe.
The committee reached the verdict based on findings from a Good Clinical Practice inspection into two clinical trial sites where AB’s supporting data for its application was generated. The investigation judged that the data gathered was not robust enough to support a registration. Specifically, the CHMP said it “did not recognise the clinical relevance of the distinction made by AB Science between patients with “normal” progression (accounting for 85% of patients in the study) and for whom an improvement on the primary endpoint – ALSFRS score – has been demonstrated, and those with “rapid” progression (accounting for 15% of patients in the study).”
Additionally, the CHMP determined that the primary analysis of ALSFRS scores for patients who stopped the study prematurely could introduce a bias into analysis of the results.
ALS is a rare degenerative condition which leads to the wasting and paralysis of the patient’s muscles. Around 50,000 people suffer from the condition in the EU and the US, with around 16,000 new cases identified every year.
AB Science responded to the rejection, vowing to provide further analysis on each of the CHMP’s concerns as part of the re-examination process, with a second opinion due to be delivered in July.
Matt Fellows
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