EMA backs five medicines; Solid Bio raises $60M in private placement
→ The European Medicines Agency on Friday recommended five new medicines for approval, including Bayer’s cancer drug Vitrakvi — the site-agnostic cancer drug was given a speedy approval by the FDA in late 2018 — and GW Pharmaceutical’s $GWPH cannabis-derived epilepsy drug Epidyolex, which was approved by the FDA last June under the name Epidiolex.
The EMA’s decision on GW’s drug is as an adjunctive therapy — for use in conjunction with clobazam. In the United States, it is approved as a monotherapy. “(T)he outcome is disappointing and a distinctly more conservative decision compared to that rendered by the FDA,” Stifel’s Paul Matteis wrote in a note. “What exactly this means for uptake is unclear because we don’t know of any good data source that codifies exactly how much clobazam is used in Europe; that being said, as we understand it, clobazam has been generic in Europe for a long time and is a staple of the Dravet/LGS/orphan epilepsy standard-of-care.”
→ Solid Bio, run by former JP Morgan investment banker who is also a Duchenne MD dad, has anything but a solid record in its quest to develop its gene therapy for Duchenne muscular dystrophy. On Friday, the company $SLDB disclosed that it had scored $60 million in a private placement to keep working on its pipeline.