FDA Approves Expanded Efficacy of Knee Osteoarthritis Pain Treatment

Osteoarthritis Knee
Osteoarthritis Knee
The FDA has given its approval for 26-week treatment efficacy claims for Zimmer Biomet's knee osteoarthritis product.

The US Food and Drug Administration (FDA) has approved an expanded efficacy claim – out to 26 weeks – for Zimmer Biomet’s hyaluronic acid injection product (Gel-One® Hyaluronate, Zimmer Biomet, Warsaw, IN) for the treatment of osteoarthritis (OA) knee pain. 

Gel-One is a single, 3mL injection provided in-office by treating physicians and is recommended for the treatment of OA knee pain when patients have not responded to therapy with nonsteroidal anti-inflammatory drugs or simple analgesics.

Hyaluronic acid treatments like this aim to supplement the natural hyaluronic acid in knee joints to increase available cushioning and lubrication. 

The FDA had previously approved an efficacy claim up to 13 weeks for the product.

“Gel-One Hyaluronate is a vital component in the continuum of treatments for knee osteoarthritis, offering millions of patients the potential for up to six months of pain relief with a single injection,” said David Nolan, president of Zimmer Biomet Group, in a press statement. “

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Zimmer Biomet announces FDA approval of expanded 26-week efficacy claim for Gel-One® Cross-Linked Hyaluronate for treatment of pain associated with knee osteoarthritis. Published online February 1, 2017. Accessed February 23, 2017.

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