3 for 3 in PhI­II: GW Phar­ma rac­ing to the FDA af­ter bag­ging an­oth­er late-stage epilep­sy suc­cess

Ex­tend­ing its win­ning streak, GW Phar­ma­ceu­ti­cals says the sec­ond Phase III for Epid­i­olex in treat­ing Lennox-Gas­taut syn­drome — a rare form of epilep­sy — has al­so come through with solid­ly pos­i­tive ef­fi­ca­cy da­ta. And the UK biotech is now plan­ning to hus­tle ahead with a new drug ap­pli­ca­tion at the FDA in the com­ing months.

The da­ta from this sec­ond study on the com­pa­ny’s lead cannabi­noid ther­a­py were even bet­ter than the first, with a me­di­an 42% drop in month­ly seizures, com­pared to 17% in the place­bo group for a 20 mg dose. The 10 mg dose was al­so a suc­cess, with a 37% drop in the seizure rate.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.