Ferring Announces U.S. FDA Acceptance of Biologics License Application Submission for SI-6603, an Investigational Therapy in Lumbar Disc Herniation
- SI-6603 is an investigational therapy intended to treat radicular leg pain associated with lumbar disc herniation
- Lumbar disc herniation can cause severe, debilitating pain
Parsippany, NJ – May 14, 2024 – Ferring Pharmaceuticals and its clinical development partner, Seikagaku Corporation (Seikagaku), today announced that the U.S. Food and Drug Administration (FDA) accepted the biologics license application (BLA) submission for SI-6603, an investigational therapy intended to treat radicular leg pain associated with lumbar disc herniation (LDH).
“Adults in the U.S. who suffer from radicular leg pain resulting from lumbar disc herniation may experience severe, debilitating pain that can affect their mobility,” said Raza Ahmed, MD, Senior Director, Medical Affairs, Specialty/Orthopedics, Ferring USA. “Ferring is working to address this unmet need and potentially provide patients with a non-surgical treatment option.”
Seikagaku submitted the BLA to the FDA. If approved by the FDA, Ferring plans to commercialize the product in the United States and has received further rights to develop, register and commercialize SI-6603 worldwide, excluding Japan.
About Lumbar Disc Herniation
About 9 million adults in the U.S. suffer from lumbar disc herniation each year. A disc herniation is a displacement (leakage) of the gel-like inner core of the intervertebral disc, called the nucleus pulposus, through its external membrane (annulus fibrosus) due to wear and tear or sudden injury. As a result of this displacement, the disc presses on the spinal nerve, often producing pain.[1],[2]
SI-6603, which contains condoliase as its active pharmaceutical ingredient, is an investigational product intended to treat radicular leg pain associated with lumbar disc herniation via a single, direct intradiscal injection.
SI-6603 was developed by Seikagaku. Marketing approval for SI-6603 in Japan was obtained from the Japanese Ministry of Health, Labour and Welfare in March 2018 and SI-6603 has been marketed in Japan only as HERNICORE® 1.25 units for intradiscal injection through Seikagaku Corporation’s Japanese sales partner Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan) since August 1, 2018.[3]
Alliance with Seikagaku
Seikagaku and Ferring entered into a license agreement for SI-6603 in August 2016. Ferring plans to commercialize the product in the United States and has received further rights to develop, register and commercialize SI-6603 worldwide, excluding Japan.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.
For more information, please visit www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn and X (Twitter).
References:
- Vialle LR, Vialle EN, Suárez Henao JE, Giraldo G. Lumbar Disc Herniation. Rev Bras Ortop. 2015 Nov 16;45(1):17-22. doi: 10.1016/S2255-4971(15)30211-1. PMID: 27019834; PMCID: PMC4799068.
- Herniated Disk in the Lower Back. OrthoInfo. American Academy of Orthopaedic Surgeons. Available at: https://orthoinfo.aaos.org/en/diseases–conditions/herniated-disk-in-the-lower-back/. Accessed May 23, 2023.
- Press Release. Seikagaku and Kaken Announce the Launch of HERNICORE® 1.25 Units for Intradiscal Injection in Japan. July 31,2018. Available at: https://www.seikagaku.co.jp/en/news/news-6617037418084939174/main/0/link/20180731-e.pdf. Accessed May 24, 2023.
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For more information, please contact:
Lisa Ellen
Director, Brand Communications
+1-862-286-5696
lisa.ellen@ferring.com