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Drug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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Tofersen
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Oligonucleotide ALS therapy approved in EU
The European Commission (EC) has granted Biogen its third rare disease treatment approval in the European Union.
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CHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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EMA accepts marketing application for ALS treatment
The EMA has accepted the marketing authorisation application for tofersen, which could be the first treatment for a rare genetic cause of ALS.
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Experimental motor neurone disease therapy shows promise
Tofersen reduced expression of the SOD1 gene known to cause amyotrophic lateral sclerosis (ALS) and slowed clinical decline in the Phase I/II trial.
