A key EMA advisory committee voted against the approval of masitinib as a treatment for ALS in Europe according to AB Science, the maker of the drug. The recommendation, known as a “negative opinion”, is based in part on concerns about the phase 3 clinical trial results and their subsequent analysis.
AB Science announced the decision on April 19.
The panel of scientific experts, known as the Committee for Medicinal Products for Human Use (CHMP), is responsible for deciding whether a drug should be marketed for clinical use in the European Union.
AB Science plans to appeal the decision. The process, known as a “re-examination”, will include additional data to address the concerns of the CHMP according to AB Science. The decision is expected to be announced by the European Medicines Agency by July 2018.
Meanwhile, in the US and Canada, a second phase 3 clinical trial is planned. Montreal Neurological Institute neurologist Angela Genge in Canada will lead the double-blind randomized placebo-controlled study. The clinical trial is anticipated to launch in the fall of 2018.
To learn more about masitinib and its potential as a treatment for ALS, check out The Phase III Results for Masitinib Are Now In. But Experts Remain Divided.
Refusal of the marketing authorisation for Alsitek (masitinib). European Medicines Agency. 20 April 2018.
Trias E, Ibarburu S, Barreto-Núñez R, Babdor J, Maciel TT, Guillo M, Gros L, Dubreuil P, Díaz-Amarilla P, Cassina P, Martínez-Palma L, Moura IC, Beckman JS, Hermine O, Barbeito L. Post-paralysis tyrosine kinase inhibition with masitinib abrogates neuroinflammation and slows disease progression in inherited amyotrophic lateral sclerosis. J Neuroinflammation. 2016 Jul 11;13(1):177. [PubMed].
Martínez-Muriana A, Mancuso R, Francos-Quijorna I, Olmos-Alonso A, Osta R, Perry VH, Navarro X, Gómez-Nicola D, López-Vales R. CSF1R blockade slows the progression of amyotrophic lateral sclerosis by reducing microgliosis and invasion of macrophages into peripheral nerves. Sci Rep. 2016 May 13;6:25663. [PubMed].