Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News Roche receives orphan drug status for rare, severe skin condition

Roche receives orphan drug status for rare, severe skin condition

7th June 2006

Roche has announced that its drug CellCept, developed in conjunction with Aspreva Pharmaceuticals, has been granted orphan drug designation by the FDA.

Orphan drug designations are granted by the FDA for drugs designed for rare diseases that are unlikely to be sold in large volumes. They offer incentives to pharmaceutical companies to continue developing these drugs. An orphan drug designation allows pharmaceutical companies a period of time in which they can market the drug exclusively, with certain tax advantages.

Although CellCept has already been used for some years as an immunosuppressant therapy for patients suffering from organ rejection following heart, kidney and liver transplants, it has not been approved for use on patients with autoimmune diseases, such as pemphigus vulgaris – a painful, chronic and severe skin blistering disease for which there are currently no “adequate treatment options”.

Peter Hug, Roche’s global head of pharma partnering, remarked: “We are very proud of our partnership with Aspreva to develop CellCept for a range of autoimmune diseases.”

“With the potential to use CellCept in pemphigus vulgaris, we may be able to offer patients living with this disease a chance for better treatment outcomes,” he added.

According to the UK’s Pemphigus Vulgaris Network, the disease is currently treated using corticosteroids and immunosuppressant drugs. It says that the disease is rare enough that many GPs have never seen the disease and as such it is mainly diagnosed by dermatologists. It is not known what triggers the disease, although there may be genetic factors involved.

track© Adfero Ltd

We currently have 10 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.