STOCKHOLM, Sweden--(BUSINESS WIRE)--Q-Med has together with its global partner Smith & Nephew agreed to the next stage in the approval process for the US launch of DurolaneTM Single Injection, Stabilized Hyaluronic Acid.
Representatives from Q-Med AB, Sweden, and Smith & Nephew met August 19th with the FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee to discuss clinical evidence for the use of DurolaneTM in the treatment of knee pain caused by osteoarthritis (“OA”).
The FDA Advisory Committee did not recommend DurolaneTM for immediate approval, requesting further information as part of the Premarket Approval (“PMA”) process for the product. Q-Med plans to work with Smith & Nephew and the FDA to provide the data required.
Smith & Nephew and Q-Med have an exclusive relationship for the global development and commercialization of Durolane. It is already marketed in 20 countries, including Canada, and has been used to treat the symptoms of OA in more than 350,000 patients worldwide.
Q-Med’s CEO and founder Bengt Ågerup said, “We are continuing the clinical development of Durolane in collaboration with Smith & Nephew to provide satisfactory clinical evidence of Durolane’s performance. We remain committed to our goal of providing U.S. physicians and patients access to a non-animal single injection product.”
Mark Augusti, President of Smith & Nephew Biologics & Spine, said: “We are committed to expanding our range of HA therapies in the United States. Use of our multi-injection SUPARTZ® Joint Fluid Therapy as a treatment for knee OA continues to increase and we are exploring its potential for other indications.”
Ken Reali, SVP and General Manager of Biologics & Spine, added: “Our meeting with the Advisory Committee on single injection Durolane provided some very useful and valuable feedback on our Premarket Approval application. We intend to work with our Q-Med partners and the FDA to initiate the next steps in making this highly successful global product available to U.S. patients.”
Smith & Nephew and Q-Med have an exclusive partnership for the global development and commercialization of Durolane. It is already marketed in 32 countries, including Canada, and has been used to treat the symptoms of OA in more than 350,000 patients worldwide.
Q-Med AB (publ), Seminariegatan 21, SE-752 28 Uppsala, Sweden. Corporate identity number 556258-6882. Tel: +46 18 474 90 00. Fax: +46 18 474 90 01. E-mail: firstname.lastname@example.org. Web: www.q-med.com.
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Bengt Ågerup, President and CEO
Tel: +46 70 974 9025
Per Langö, Senior Director Corporate Development
Tel: +46 73 387 1521