Ferring Announces FDA Advisory Meeting for SI-6603 in Lumbar Disc Herniation

Ferring Pharmaceuticals and its clinical development collaborator, Seikagaku Corporation, have revealed that the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee will convene on January 10, 2025. This meeting aims to review data supporting the biologics license application (BLA) for SI-6603, also known as condoliase. This investigational drug is being evaluated for treating radicular leg pain associated with lumbar disc herniation (LDH) in adults.

Brent Ragans, the President of Ferring Pharmaceuticals in the U.S., highlighted the limited treatment options currently available for the numerous Americans suffering from radicular leg pain due to lumbar disc herniation each year. He emphasized that existing treatments are primarily conservative pain management, physical therapy, or surgery. Ragans expressed the significant unmet need for these patients and reaffirmed Ferring’s commitment to addressing this gap in collaboration with Seikagaku.

The FDA plans to live stream the advisory committee meeting, and a webcast will also be available on its website.

Lumbar disc herniation affects approximately 9 million adults annually in the United States. It occurs when the gel-like nucleus pulposus of the intervertebral disc displaces through its outer membrane, the annulus fibrosus, due to factors such as wear and tear, aging, or sudden injury. This displacement causes the disc to press on the spinal nerve, which often results in pain.

SI-6603, which contains condoliase as its active ingredient, is under investigation for its potential to alleviate radicular leg pain caused by lumbar disc herniation in adults through a single, direct intradiscal injection. Condoliase is designed to minimize nerve root compression, thereby reducing radicular leg pain.

Developed by Seikagaku, SI-6603 received marketing approval in Japan from the Japanese Ministry of Health, Labour and Welfare in March 2018. The product has been commercially available in Japan under the name HERNICORE® 1.25 units for intradiscal injection since August 1, 2018, through Seikagaku’s Japanese sales partner, Kaken Pharmaceutical Co., Ltd.

The partnership between Seikagaku and Ferring began in August 2016 through a license agreement for SI-6603. Ferring intends to market the product in the United States following FDA approval and has obtained rights to develop, register, and commercialize SI-6603 globally, excluding Japan.

Ferring Pharmaceuticals is a privately-owned, research-driven specialty biopharmaceutical group focused on improving lives and building families. In the U.S., Ferring is a leader in reproductive medicine, maternal health, gastroenterology, and orthopaedics. The company is also at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Founded in 1950, Ferring is headquartered in Saint-Prex, Switzerland, and employs over 7,000 people worldwide, with its products available in more than 100 countries. Ferring USA, based in Parsippany, New Jersey, employs over 900 individuals.