LONDON (Reuters) - Sanofi and Regeneron’s new cholesterol drug Praluent could be recommended for approval in Europe as early as this week, along with the world’s first malaria vaccine from GlaxoSmithKline.
A European green light for Praluent would put the closely watched so-called PCSK9 drug two months behind Amgen’s rival product Repatha, which was formally approved by the European Commission on Tuesday after a positive opinion in May.
According to an agenda posted on the European Medicines Agency's (EMA) website, a committee of experts will consider whether to recommend Praluent and GSK's malaria vaccine at a four-day meeting concluding on July 23. (here)
The EMA usually communicates its decisions on the Friday after the meeting ends, or July 24.
The fact that the products are being discussed this week does not automatically mean a decision will be taken, since experts may decide they have further questions.
Recommendations for marketing approval by its Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
The development of GSK’s malaria vaccine — called RTS,S or Mosquirix — has been backed by billionaire philanthropist Bill Gates and is designed for use in sub-Saharan Africa, where malaria kills one child almost every minute.
Reporting by Ben Hirschler, editing by Louise Heavens