Condoliase(Seikagaku Corp.)

Japan-based Seikagaku will face an FDA advisory committee on Friday, with the agency raising concerns ahead of the meeting regarding the efficacy of its condoliase injection for the treatment of radicular leg pain associated with lumbar disc herniation in adults. Ahead of the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the FDA notes that one of the clinical trials failed on its primary endpoint. Overall, the agency sounded positive on an approval, noting in briefing documents released Wednesday that “the negative study may inform the benefit-risk assessment for specific populations who may be considered for treatment with condoliase if the product is approved.” One of the three clinical trials evaluated by the FDA did not meet its primary efficacy endpoint (change in worst leg pain from baseline to week 13), nor did it meet either of its two key secondary endpoints, including a pain outcome assessment after a year. The change from worst leg pain from baseline to week 52 slightly favored the control in the failed study, FDA said, but the difference was not statistically significant. The agency also noted that the study that failed likely did so because herniation resulting in symptomatic nerve impingement was not present in most of the patients enrolled, and that’s what the injection targets. The agency said that Seikagaku “performed a detailed analysis to explain the negative U.S. findings despite the positive findings in Study 1031 in Japan.” The company highlighted two key issues: 1) A majority of patients in the failed trial did not have definitive impingement of the nerve root by the disc herniation on an MRI. 2) Baseline back pain was significantly higher in the US study compared to the study in Japan. Two other Phase 3 clinical trials were positive, although one was conducted exclusively in Japan. And in both trials, nerve impingement conducive to condoliase treatment was confirmed by imaging, FDA said. Friday’s committee will have an up-or-down vote on the injection, with the question presented as, “Do the benefits of condoliase injection for treatment of radicular leg pain associated with confirmed nerve root impingement caused by lumbar disc herniation in adults with radicular leg pain outweigh the risks?” Seikagaku, which also markets an intra-articular injection for the treatment of knee osteoarthritis in the US, calls its condoliase injection an improvement on the current treatment landscape, because it does not require general anesthesia and is “less invasive to the patient than surgical treatment.”

PARSIPPANY, N.J.--( BUSINESS WIRE )--Ferring Pharmaceuticals and its clinical development partner, Seikagaku Corporation (Seikagaku), today announced that the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (FDA) will hold a meeting on January 10, 2025, to review data supporting the biologics license application (BLA) for SI-6603 (generic name: condoliase), an investigational product being studied for the treatment of radicular leg pain associated with lumbar disc herniation (LDH) in adults. “ Treatment options for the millions of Americans who suffer from radicular leg pain associated with lumbar disc herniation each year are currently limited to conservative pain management and physical therapy or surgery, ” said Brent Ragans, President, Ferring Pharmaceuticals, U.S. “ This represents a significant unmet patient need, and Ferring, in partnership with Seikagaku, is working to address this treatment gap. ” The FDA will live stream the advisory committee meeting and a webcast of the meeting will also be available on the FDA website. 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 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, aging or sudden injury. As a result of this displacement, the disc presses on the spinal nerve, often producing pain. 1,2 About SI-6603 SI-6603, which contains condoliase as its active pharmaceutical ingredient, is an investigational product being studied for the treatment of radicular leg pain associated with lumbar disc herniation in adults via a single, direct intradiscal injection. SI-6603 (condoliase) is designed to reduce nerve root compression and thereby the radicular leg pain. 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'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 upon FDA approval 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.