GW Pharma’s cannabis-derived epilepsy medicine tends to make the reduce in the European Union – Endpoints News

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GW Phar­ma’s cannabis-de­rived med­i­cine for epilep­sy has won Eu­ro­pean en­dorse­ment, a lot more than a year af­ter the British drug­mak­er se­cured its land­mark US ap­proval.

The med­i­cine, chris­tened Epidy­olex in the EU, is a plant-de­rived for­mu­la­tion of cannabid­i­ol (CBD). It was ap­proved in June by the US au­thor­i­ties and launched in the re­gion in No­vem­ber. The Lon­don-primarily based com­pa­ny gen­er­at­ed near­ly $102 mil­lion sell­ing the drug in the initial half of this year — and has treat­ed more than 12,000 pa­tients in the Unit­ed States.

On Mon­day, GW $GW­PH stated the drug had been sanc­tioned for use in pa­tients with ei­ther Lennox‑Gas­taut syn­drome (LGS) or Dravet syn­drome — two uncommon, and no­to­ri­ous­ly difficult-to-treat types of child­hood-on­set epilep­sy char­ac­ter­ized by per­sis­tent seizures — in con­junc­tion with clobazam. The Eu­ro­pean Med­i­cines Agency has ap­proved the drug for use across the Eu­ro­pean Union, along­side Nor­way, Ice­land, and Liecht­en­stein.

Can­tor Fitzger­ald’s El­e­mer Piros ex­pects GW to gen­er­ate $53 mil­lion in Eu­ro­pean sales subsequent year, and an­tic­i­pates the drug will rake in close to $500 mil­lion in 2025, with a peak mar­ket pen­e­tra­tion of 30%, he wrote in a note on Mon­day.

In the Unit­ed King­dom, a con­cert­ed cam­paign to un­lock the use of cannabis to treat se­vere child­hood epilep­sy prompt­ed the British au­thor­i­ties final year to sanc­tion its use in cer­tain pa­tients, when oth­er med­i­cines have failed, af­ter con­sul­ta­tion with a spe­cial­ist doc­tor.

How­ev­er, final month NHS Eng­land and expense-ef­fec­tive­ness watch­dog Good is­sued a state­ment sug­gest­ing the re­search on the use of cannabis (or its de­riv­a­tives) was not com­pelling sufficient to jus­ti­fy its med­ical use, cit­ing the lack of ran­dom­ized con­trol tri­al (RCT) as a ma­jor hur­dle to pre­scrib­ing amongst oth­er con­cerns. Good al­so failed to back the use of GW’s drug — al­though ne­go­ti­a­tions be­tween the two are on­go­ing.

The his­toric FDA ap­proval of GW Phar­ma’s cannabis drug ear­li­er this year paved the way for a pletho­ra of compact and mid-sized drug de­vel­op­ers — in­clud­ing Zyner­ba $ZYNE, In­Med Phar­ma, Kan­nal­ife and Ax­im Biotech $AX­IM who are ei­ther de­vel­op­ing syn­thet­ic or nat­ur­al cannabis-de­rived ther­a­peu­tics or de­vis­ing nov­el de­liv­ery mech­a­nisms for its ab­sorp­tion, to treat a pletho­ra of med­ical con­di­tions.

Even massive phar­ma now has its paws in the bur­geon­ing field — Swiss gi­ant No­var­tis’ $NVS San­doz AG unit has tied up with Cana­di­an med­ical cannabis pro­duc­er Tilray and med­ical cannabis grow­er Can­ndoc has tied up with Te­va’s $TE­VA SLE group to dis­trib­ute its med­ical cannabis prod­ucts in Is­rael.

So­cial im­age: Shut­ter­stock

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