24/10/2016

Fidia farmaceutici’s collagenase has been granted Orphan Drug Designation

Designation by the US FDA for the treatment of advanced Dupuytren’s disease

Abano Terme, October 18, 2016 - Fidia Farmaceutici announced the obtainment of Orphan Drug Designation by the US Food and Drug Administration, for its Vibrio alginolyticus collagenase, produced and purified in the R&D Unit in Noto (Sicily), for the treatment of advanced Dupuytren’s disease (Dupuytren’s contracture).

Fidia Farmaceutici, world leader in the research and development of hyaluronic acid-based products, is one of the few Italian companies eligible to receive, over the last few years, the Orphan Drug Designation by the FDA, assigned to pharmaceutical agents that have been developed specifically to treat a rare medical condition.

Dupuytren’s contracture is a fibrosing hand disorder that results in slowly progressive thickening and shorting of the palmar fascia and can present with palpable collagen ‘cords’ that limit finger movement and hand function (the fingers bend towards the palm and cannot be fully extended), thereby affecting the patient’s quality of life.

Fidia Farmaceutici is developing an innovative therapeutic solution for Dupuytren’s contracture based on the combination of collagenase and hyaluronic acid: on the one hand, the collagenase enzyme breaks down the collagen fibers in the contracting “cords” caused by excessive deposition; on the other hand, hyaluronic acid protects the surrounding tissues, thereby favouring functional repair and helping the patient regain full hand movement.

The company owns patents on Vibrio alginolitycus collagenase and compositions thereof, containing also hyaluronic acid, for various therapeutic applications, such as Dupuytren’s disease, where this therapy is proposed as a safe, non-surgical option to address an important, unmet need and improve the quality of life for people with this painful hand condition.

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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