16 Jul 2018 by AXXELIS
FDA approves Epidiolex, the first marijuana-based pharmaceutical
On June 25th the FDA-approved Epidiolex (GW Pharmaceuticals plc), a cannabidiol (CBD) based drug to treat both Lennox-Gastaut and Dravet syndromes, two rare forms of epilepsy. Epidiolex is the first drug product based on an active ingredient in marijuana approved for use in the US and is the first drug approved to treat Dravet syndrome. The FDA’s approval of Epidiolex indicates that CBD will have to be rescheduled under the Drug Enforcement Agency (DEA) and that marijuana-based compounds have a legitimate path to the US market…
FDA Approves Amgen and Novartis Migraine Drug Aimovig, Expected to Be Ready for Patients in 1 Week
Amgen and Novartis scored a big win in the migraine market late Thursday when the U.S. Food and Drug Administration (FDA) approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The drug will launch with a list price of $6,900 per year and is expected to be available within a week.
The migraine medication was approved based off of stunning Phase III data that showed Aimovig reduced monthly migraine attacks in half. The medication developed by the two powerhouse companies is the only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R). CGRP is believed to play a significant role in migraine and cluster headaches. A dedicated Phase IIIb study in difficult-to-treat populations, patients who have episodic migraines but have failed two to four prior treatments, showed that patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo.