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Biologics Feature

Courtesy of Bioventus LLC

Rare FDA Approval for Bioventus Joint Lubrication

Walter Eisner • Tue, September 19th, 2017

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Bioventus LLC scored a rare orthopedic FDA Premarket Approval (PMA) on August 29, 2017, for its single-injection hyaluronic acid (HA) joint lubrication product Durolane.

Over 20 million Americans suffer pain from knee osteoarthritis (OA). But, said company CEO Tony Bihl, the associated pain can be managed. Durolane has been a "proven knee OA pain reliever for more than 15 years, improving the lives of more than one million people worldwide."

PMA are big deals because companies prefer to go through the cheaper, faster and less complicated 510(k) process where the company only has to show that a "predicate device" exists in previous approvals. The PMA process is saved for truly unique devices and treatments, with very expensive clinical trials and years of data gathering to prove safety and effectiveness.

So, what makes Durolane so unique without a predicate?

Originality.

Knee osteoarthritis involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates knee joint tissues. The company says Durolane is the original single-injection joint-fluid treatment which contains high levels of non-animal stabilized hyaluronic acid (NASHA®) technology. Hyaluronic acid is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. It is injected into indicated joints

The company says the product is the only HA treatment for OA that is based on NASHA. That technology is the component of several medical products that use this unique HA and its properties to provide healthcare solutions.

The technology has an advanced patented process of HA. It is a highly purified product produced without using any animal-sourced materials, ensuring that the risk of impurities is close to zero. The product is treated by the body in the same way as the body’s own hyaluronic acid and there have been no reported cases or instances of immunological or anaphylactic reactions.

The original clinical development of Durolane was founded upon three randomized, controlled trials. The initial two trials were superiority studies versus saline; the third was a non-inferiority trial versus the commonly used corticosteroid, methylprednisolone acetate.

Benefits

According to the company, the potential benefits of Durolane include:

  • Directly treats the affected joint
  • Treatment is repeatable as required by your physician
  • May help to avoid or delay hip or knee replacement surgery
  • Long-term freedom from osteoarthritis pain
  • Simple & quick to administer
  • Drug-free alternative to pills

Indications

In the U.S., symptomatic treatment of mild to moderate knee osteoarthritis. Outside the U.S., says the company, Durolane has been approved for the symptomatic treatment associated with mild to moderate arthritis pain in the hip, ankle, shoulder, elbow, wrist, fingers, and toes. Outside the U.S., the product is also indicated for pain following joint arthroscopy either in the presence of osteoarthritis or subsequent to general surgical repair within three months of the procedure.

Contraindications

There are no known contraindications. You should not use Durolane, says the company, “if you have infections or skin disease at the injection site. Durolane has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site. Clinical effectiveness has been demonstrated out to six months but results may vary depending on various patient factors.”

Continued approval of the PMA is contingent upon the submission of periodic reports at intervals of one year from the date of approval.

Bioventus acquire some of the Durolane assets from Galderma in 2014. The PMA was submitted in March 2017, resulting in a five-month review process. The product has been CE marked within the European Union since 2001 and is marketed globally.

To read the FDA Summary of Safety and Effectiveness Data, click here.

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Comments

2 Responses to “Rare FDA Approval for Bioventus Joint Lubrication”

  1. Thomas Hill says:

    The FDA approval for use in the US covers indications for knee OA only which is outlined in our press release. The reporter has included OUS indications for DUROLANE. We pointed out the error to Walter Eisner several days ago and he indicated he would correct the piece but it appears he has not done so.

  2. Carolyn Kong says:

    We would like to clarify that all of the IA-HAs are approved via a PMA route in the US. None are approved via a 510(k) route. A company does not have the option to choose one way over the other. A 510(k) is not an option for this type of product. Thus, the Durolane approval is not rare because all 13 IA-HAs have been approved via the PMA route.

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