CHMP recommends rejecting Amylyx ALS drug, pitting EMA against FDA and Health Canada

The Eu­ro­pean Med­i­cines Agency rec­om­mend­ed that Amy­lyx Phar­ma­ceu­ti­cals’ ALS drug be re­ject­ed with­in the EU.

The drug, known as Re­lyvrio in the US and Al­bri­oza in Cana­da and the EU, did not “con­vinc­ing­ly” show that it could slow the wors­en­ing of ALS in a clin­i­cal tri­al, the EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) said Fri­day. As a re­sult, reg­u­la­tors could not say for cer­tain that the ben­e­fits out­weigh the risks.

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