Biogen's SKYCLARYS Gets CHMP Recommendation For Marketing Authorization

(RTTNews) - Biogen Inc. (BIIB) on Friday made an announcement regarding the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the marketing authorization for SKYCLARYS (omaveloxolone), for treating Friedreich's ataxia in both adults and adolescents aged 16 years and above.

If the European Commission (EC) approves SKYCLARYS, it will become the first authorized drug for treating this rare, genetic, progressive neuromuscular condition in the European Union.

The positive opinion of SKYCLARYS by CHMP is based on the placebo-controlled MOXIe Part 2 trial's efficacy and safety data, as patients who received SKYCLARYS showed less physical impairment in comparison to those who were given a placebo, as determined by the modified Friedreich Ataxia Rating Scale (mFARS).

The company stated that the EC will review CHMP's recommendation for SKYCLARYS to obtain marketing authorization in the European Union, with a final decision expected in the first quarter of 2024.