New EU Filings Include First-Of-Its-Kind MS Drug Tolebrutinib & HIV Prophylaxis Lenacapavir

Several new drugs that are yet to be approved anywhere in the world are now under review by the European Medicines Agency for potential pan-EU marketing authorization.

Neurodegenerative disease concept 3d illustration — Tolebrutinib is an oral, brain-penetrant and bioactive BTK inhibitor for treating multiple sclerosis (Shutterstock)

Key Takeaways

The European Medicines Agency has started reviewing the marketing authorization applications for eight new drugs – tolebrutinib, lenacapavir, levodopa/carbidopa, estetrol, aflibercept, teriparatide, and two midazolam products.

Tolebrutinib, Sanofi’s investigational treatment for non-relapsing secondary progressive multiple sclerosis (nrSPMS), is among the latest products that the European Medicines...