This week’s industry news round-up reveals the latest updates including a new medicine for migraine, a rescheduling of cannabidiol for epilepsy and a successful Phase III trial for neuromyelitis optica spectrum disorder. Find out more about our selection of the highlights below.
Our selection of the highlights includes:
- Emgality™ receives marketing authorization for the prevention of migraine
- Alexion reveals positive results for Soliris® in patients with neuromyelitis optica spectrum disorder
- GW Pharmaceuticals announces DEA reschedule of Epidiolex® for epilepsy
Emgality™ receives marketing authorization for the prevention of migraine
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Emgality™ (galcanezumab), a monoclonal antibody for the prevention of migraine.
Emgality belongs to a class of medicines that work by blocking the activity of CGRP, and is the second monoclonal antibody therapy for the prevention of migraine to be recommended for authorization, following the positive opinion for Aimovig® (erenumab) in May 2018. The drug will be available as a solution for injection only for patients who have had at least 4 migraine days per month.
The benefits and safety of Emgality were studied in three pivotal trials involving 1780 patients with episodic migraine and 1117 with chronic migraine. After 6 months of treatment, patients with episodic migraine showed a reduction of 1.9 monthly migraine days on average compared with placebo. For patients with chronic migraine the reduction was 2 days. The most common side effects were pain and reactions at the injection side, vertigo and constipation.
The opinion adopted by the CHMP is an intermediary step on Emgality’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. Once a marketing authorization has been granted, decisions about price and reimbursement will take place, taking into account the potential role/use of this medicine in the context of the national health system of that country.
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Alexion reveals positive results for Soliris® in patients with neuromyelitis optica spectrum disorder
Alexion Pharmaceuticals (MA, USA) has announced positive top-line results from the Phase III PREVENT study of Soliris® (eculizumab) in patients with anti-AQP4 auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD).
NMOSD is a rare, devastating, complement-mediated disorder of the CNS characterized by relapses. There are currently no approved therapies for this disease.
The study met its primary endpoint of time to first adjudicated on-trial relapse, demonstrating that treatment with Soliris reduced the risk of NMOSD relapse by 94.2% compared with placebo (p < 0.0001). At 48 weeks, 97.9% of patients receiving the drug were free of relapse compared with 63.2% of patients receiving placebo.
“The primary goal in treating NMOSD is relapse prevention as each relapse further increases disability, which makes this disease so devastating,” commented Michael Levy (Johns Hopkins University, MD, USA). “The substantial effect of Soliris seen in this groundbreaking randomized, controlled study in NMOSD could potentially become a turning point for patients and their families who live in constant fear of relapse.”
Detailed results from the Phase III study will be presented at a future medical congress.
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GW Pharmaceuticals announces DEA reschedule of Epidiolex® for epilepsy
GW Pharmaceuticals (CA, USA) has announced that Epidiolex® (cannabidiol) oral solution has been transferred to Schedule V, the lowest restriction classification, by the US Drug Enforcement Administration.
Epidiolex was approved by the US FDA in June 2018 for the treatment of seizures associated with Lennox–Gastaut syndrome or Dravet syndrome in patients 2 years of age or older. It is the first prescription pharmaceutical formulation of highly purified plant-derived cannabidiol.
“With this final step in the regulatory process completed, we are working hard to make Epidiolex available within the next 6 weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA,” explained Justin Gover, Chief Executive Officer of GW Pharmaceuticals.
With this decision, the product label for Epidiolex will be finalized. Availability is primarily dependent on the time involved in obtaining the required Schedule V licenses for the US distributor and importer.
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