Gottlieb: Epidiolex Approval Covers One Specific Cannabidiol Medication, Not Marijuana
The approval for the GW Pharmaceuticals drug covers the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two forms of rare and severe childhood epilepsy – the US agency was quick to clarify what the approval did not cover, chiefly marijuana.
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Finance Watch: Panic Over FDA Commissioner's Resignation Was Short-Lived, Though IPOs Still Languish
Public Company Edition: Biotech stocks sank when US FDA Commissioner Scott Gottlieb announced his departure, but have nearly recovered to pre-resignation levels, except for newly public firms. Also, Biohaven's raises cash for PRV purchase and Endo issues $1.5bn in new debt.
Biocodex's Diacomit – long approved in the EU – just won FDA approval. That brings the number of drugs cleared for Dravet in the US to two, including GW Pharma's recently endorsed Epidiolex, and the R&D pipeline for this rare seizure disorder is growing.
Strong efficacy and a clean safety profile – with no cardiovascular signal – in another Phase III study bode well for filings of Zogenix's ZX008 in the fourth quarter.