CysviewTreatment for Diagnostic
Update: Cysview (hexaminolevulinate) Now FDA Approved - May 28, 2010
Photocure ASA (NO) - Hexvix has been granted priority review by the FDA
Oslo, Norway, 31 August 2009 --Photocure announces today that the US Food and Drug Administration (FDA) has designated priority review for the Hexvix New Drug Application (NDA).
The NDA was submitted to the FDA 30 June 2009 to obtain approval for Hexvix for use in the detection of papillary bladder cancer using fluorescence cystoscopy.
The standard target review time of an NDA is 10 months from the submission. A priority review has a target review time of 6 months. FDA assigns priority review to products which the FDA considers to provide a significant improvement over current standard of care.
Photocure's Licence Agreement with GE Healthcare includes a milestone of EUR 10 million at an approval of Hexvix in combination with blue light cystoscopy (NDA and PMA).
Hexvix has been approved for use in diagnosis of bladder cancer in Europe since 2005, and its usefulness is acknowledged by the fact that fluorescence cystoscopy, for which Hexvix is the only approved drug on the global market, is recommended in the European Association of Urology's guidelines. The cystoscopic procedure is used for bladder mapping, guiding of biopsies in suspect areas of the bladder and trans urethral resection of the bladder (TURB), i.e. removal of cancerous bladder tissue.
Kjetil Hestdal, President and CEO of Photocure comments: " This was very good news, and we are happy that FDA acknowledge that Hexvix can have a major medical benefit for bladder cancer patients. In addition, a shorter review time enables an earlier introduction of Hexvix on the US market by Photocure's licence partner, GE Healthcare."
Photocure ASA is a Norwegian pharmaceutical company founded in 1993 and listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the detection of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
Photocure®, Metvix®, Hexvix® and Aktilite® are registered trademarks of Photocure ASA.
For further information, contact: Photocure ASA Attn. Kjetil Hestdal (President and CEO) or Christian Fekete (CFO) Hoffsveien 48 NO-0377 Oslo, Norway www.photocure.com
Posted: September 2009
- Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer - June 2, 2010
- FDA has posted an Advisory Committee meeting with Photocure to discuss Hexvix NDA - November 23, 2009
- Photocure submits application for marketing approval for Hexvix in USA to the FDA - July 1, 2009
- FDA Requests More Information Related to Hexvix NDA - April 20, 2006