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.
- Lenacapavir, from Gilead Sciences, is a twice-yearly injectable HIV-1 capsid inhibitor for the prevention of HIV, which the EMA is fast tracking.
- It is being by reviewed by the EMA in parallel with another marketing application for the product that Gilead has submitted under the EU-Medicines for all (EU-M4all) pathway, which is designed to facilitate the availability of medicines in low- and lower-middle-income countries.
- Levodopa/carbidopa (ND0612) is Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy – a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa – for the treatment of motor fluctuations in people with Parkinson's disease
Tolebrutinib, Sanofi’s investigational treatment for non-relapsing secondary progressive multiple sclerosis (nrSPMS), is among the latest products that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.
The oral, brain-penetrant, and bioactive Bruton’s tyrosine kinase inhibitor is a first of its kind medicine for nrSPMS, according to Sanofi, which said there were no approved treatments available for...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?