Argent BioPharma’s (ASX: RGT) flagship CannEpil cannabinoid-based therapy for the treatment of refractory (or drug-resistant) epilepsy has been approved for prescription in Germany under a special access scheme.
The approval means that doctors can now prescribe the drug to eligible patients, who may also qualify for health insurance coverage depending on the doctor’s recommendation and case assessment.
It represents a significant step in Argent’s European expansion strategy and strengthens its presence in the German market, a key pharmaceutical hub.
Argent plans to work towards raising CannEpil’s German profile through education programs for medical professionals and the expansion of distribution channels through key regional partners.
The company will also monitor market updates and patient outcomes to support the product’s ongoing research and development.
Argent expects the prescription approval to pave the way for broader penetration into other markets within the European Union that have similar regulatory pathways.
The approval also underscores the increasing acceptance of cannabinoid-based medicine for central nervous system disorders and positions CannEpil as an accessible treatment that offers a vital alternative for patients with limited therapeutic options.
Managing director Roby Zomer said the German approval aligns with Argent’s mission to innovate and expand the reach of new medical solutions and would ensure life-changing access for patients who need it most.
“The approval of CannEpil in Germany represents a significant milestone for Argent and the patients who rely on innovative treatments for epilepsy,” he said.
“It marks our continued expansion in Europe and reinforces our commitment to improving lives through cutting-edge cannabinoid-based medicine.”
Epilepsy is a chronic neurological disorder characterised by recurring seizures caused by abnormal electrical activity in the brain, which leads to changes in movement, sensation, behaviour or awareness.
Approximately 816,000 people in Germany are currently diagnosed with epilepsy and a substantial portion of these patients suffer from drug-resistant forms, imposing a significant burden on sufferers and the community.
Current treatment options remain limited and highlight the critical need for novel therapeutic approaches.
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