Teijin Pharma Limited has achieved a significant regulatory milestone in Japan with the approval of XEOMIN (incobotulinumtoxinA) for treating chronic sialorrhea, becoming the first drug approved for this indication in the country. The approval from Japan's Ministry of Health, Labor and Welfare (MHLW) represents a breakthrough for patients suffering from this debilitating condition.
Clinical Evidence and Mechanism of Action
The MHLW approval is based on comprehensive Phase III clinical trials conducted by Merz Therapeutics in Germany and Poland, along with additional trials conducted by Teijin in Japan. XEOMIN demonstrates efficacy by inhibiting the release of acetylcholine from cholinergic nerve endings, which reduces the secretion of water and electrolytes from the salivary glands, effectively suppressing excessive saliva production.
The drug is formulated as a highly purified neurotoxin, with botulinum toxin type A as the only active ingredient. This purification is achieved through specialized technology developed by Merz Pharma GmbH & Co. KGaA, which removes complexing proteins from botulinum toxin type A produced from Clostridium botulinum.
Addressing Significant Unmet Medical Need
Chronic sialorrhea affects patients with various underlying nervous system conditions, including Parkinson's disease, atypical parkinsonism, stroke, brain injury, cerebral palsy, amyotrophic lateral sclerosis, and muscular dystrophy. The condition severely impacts patients' daily lives, causing them to refrain from social activities due to drooling symptoms and creating difficulties with speaking and eating.
"Teijin Pharma has set a long-term vision of becoming a company that solves the challenges of patients, families and communities who need more support with rare and intractable diseases," said Masaki Taneda, President of Teijin Pharma. "We are pleased to offer this new treatment option to patients in Japan with chronic sialorrhea."
Global Reach and Strategic Partnership
XEOMIN is currently approved in 81 countries worldwide for therapeutic and aesthetic indications, with approval in 51 countries specifically for chronic sialorrhea treatment. The success in Japan stems from a strategic partnership established in 2017, when Teijin Limited signed an exclusive license and co-development agreement with Merz for XEOMIN in Japan. The company launched exclusive sales of XEOMIN in Japan in December 2020 following initial manufacturing and sales approval.
Stefan König, CEO of Merz Therapeutics, emphasized the importance of the partnership: "At Merz Therapeutics, we are committed to bringing better outcomes to patients with neurological diseases, and with strong partnerships like Teijin, we can maximize our efforts and reach. I am proud that Teijin has achieved this important milestone in providing the first treatment in Japan for people living with chronic sialorrhea."
Impact on Patient Care
The approval addresses a significant burden that extends beyond patients to their families and caregivers, who must manage complex hygiene and health issues associated with chronic sialorrhea. The ability to manage this distressing condition represents a meaningful advancement in improving quality of life for affected patients in Japan.
This regulatory success demonstrates the continued expansion of XEOMIN's therapeutic applications and reinforces the value of international partnerships in bringing innovative treatments to patients with rare and challenging conditions.
