09/09/2015

FDA Approval for Marketing Hymovis in the United States

Fidia Farmaceutici’s Italian excellence grows in the US market with its latest generation hyaluronic acid

The FDA’s Center for Devices and Radiological Health (CDRH) has approved the PMA (Pre Market Approval) application for Hymovis from Fidia Farmaceutici, indicated for the intra-articular therapy of osteoarthritis based on hyaluronic acid, designed to remain longer in the joint. This information comes from the company, which is a world leader in the research, development and manufacturing of products based on hyaluronic acid.

The green light from the American regulatory agency will allow Fidia Farmaceutici to increase its share in the most important and innovative pharmaceutical market in the world, that accounts for approximately 1.200 billion dollars in the viscosupplementation segment, equivalent to 68% of the global market (which is about 1.7 billion).

"The FDA approval of Hymovis is a great success for us not only in terms of expansion and consolidation of the Group’s presence in the United States, where we have a solid presence with Fidia Pharma USA, but above all, as recognition at an international level of the quality of Fidia’s brand, as well as Italian research and products" stated Giorgio Foresti, CEO of the company based in Abano Terme (Padova, Italy).

"In view of the growing internationalisation of Fidia Farmaceutici - continued Giorgio Foresti – all the necessary conditions exist for new business projects, even overseas, which will allow us to export technological and biotechnological research and know-how from our P&R Holding, thereby confirming Fidia’s Italian excellence worldwide, in the field of hyaluronic acid and treatments of osteoarticular pathologies".

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Key Business Areas

Fidia operates in numerous therapeutic areas, providing specific, innovative treatments for commonly occurring pathologies with major socio-economic impact, namely:

- joint healthcare
- ophthalmology
- wound care
- dermatology
- neurology
- dermo-aesthetics