CysviewTreatment for Diagnostic
Update: Cysview (hexaminolevulinate) Now FDA Approved - May 28, 2010
FDA has posted an Advisory Committee meeting with Photocure to discuss Hexvix NDA
OSLO, Nov. 20, 2009-Hexvix new drug application (NDA) will be discussed in Oncologic Drugs Advisory Committee meeting scheduled for 17th December 2009.
Photocure submitted the NDA on 30 June 2009 and achieved a priority review scheduled to be completed by 30 December 2009. The NDA includes data from from 1 pivotal and 4 supportive phase 3 studies. The Pivotal phase 3 study in 814 included patients showed a significantly improved detection (p=0.001) of non-invasive papillary cancer using Hexvix cystoscopy compared to standard white light cystoscopy in patients with non-invasive papillary bladder cancer. The improved detection was followed by a significant reduction (p= 0.026) in recurrence at 9 months. All supportive Phase 3 studies confirmed the improved detection using Hexvix. The reduction in recurrence was similar in a Danish Phase 3 supportive study.
According to US Law all New Chemical Entities (NCE), such as hexaminolevulinate in Hexvix, should be subject to an Advisory Committee meeting prior to approval by the FDA.
The FDA has 32 advisory committees, of which one is the Oncologic Drugs Advisory Committee that will review Hexvix. Advisory committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies, FDA generally follows an advisory committee's recommendation, but is not bound to do so.
Kjetil Hestdal says:" We are happy to see that the review is progressing in accordance with the time lines provided by FDA and we are well prepared to present Hexvix to the advisory committee".
Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.
Photocure's commercial activities includes own marketing and sales in selected markets as well as out-licensing to leading pharmaceutical companies on a regional or global basis prior to phase III.
Photocure has one proprietary pharmaceutical product on the market: Hexvix, for the diagnosis of bladder cancer. Hexvix is approved in EU and under priority review by FDA in the US. In addition, the company has developed a proprietary light source, which is used in combination with the Visonac(TM) cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products based on the Photocure Technology(TM) platform.
For more information about Photocure, visit our website at www.photocure.com.
Photocure®, the Photocure logo and Hexvix® 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: November 2009
- Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer - June 2, 2010
- Photocure ASA (NO) - Hexvix has been granted priority review by the FDA - September 1, 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