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Bioibérica obtains approval for its chondroitin sulfate as an ethical drug in osteoarthritis in five more European countries

3 Mar 2015
Healthcare
  • The European Medicines Agencies of Austria, Hungary, the Czech Republic, Italy and Poland revalidate the efficacy and safety of this drug
  • With these new approvals, Bioibérica brand chondroitin sulfate is now approved as a medicinal product in a total of a seven European countries, furthering the company's international expansion plan in the field of osteoarthritis

Bioibérica's chondroitin sulfate, a symptomatic slow-acting chondroprotective drug indicated in the treatment of osteoarthritis, has been approved as an ethical drug in Austria, Hungary, the Czech Republic, Italy and Poland, through a mutual recognition procedure from Finland. It is now approved as a medicinal product in 13 European countries, and in seven, including Spain, it is under the Bioibérica brand.

This approval confirms the European Medicines Agencies' revalidation of the efficacy and safety of chondroitin sulfate. It is an extensively-studied drug with solid scientific backing; it has been proven to reduce pain and improve mobility in individuals suffering from osteoarthritis and also offers clear safety advantages”, stated Dr. Josep Vergés, clinical pharmacologist and Medical and Scientific Director of Bioibérica.

Specifically, in parallel with the new approvals of the drug, The Cochrane Library has published a review on chondroitin sulfate confirming its efficacy and safety in the treatment of osteoarthritis. The conclusions reveal that the patients treated with chondroitin sulfate present a statistically significant and clinically relevant improvement of pain and functional capacity versus placebo. Another recent study certifying its clinical efficacy is the MOVES clinical trial published in Annals of the Rheumatic Diseases, which concludes that the combination of chondroitin sulfate and glucosamine has comparable efficacy to the anti-inflammatory celecoxib after six months of treatment in severe osteoarthritis.

With these new approvals, Bioibérica brand chondroitin sulfate is now approved as a medicinal product in a total of a seven European countries, furthering the company's international expansion plan in the field of osteoarthritis.

For 2015, Bioibérica plans to launch its product in the 5 new countries that have authorized the drug, for which it has entered license and distribution agreements with local companies specializing in the osteoarticular field.

In Europe, chondroitin sulfate is approved as a medicinal product in Spain, Portugal, Italy, France, Switzerland, Austria, Hungary, Ireland, Finland, the Czech Republic, Slovakia, Romania and Poland.