Shire PDUFA date expected (LSE:SHP, NASDAQ:SHPGY)

On November 4, 2009, Shire plc (LSE:SHP, NASDAQ:SHPGY), which is a specialty biopharmaceutical company that is operating in several countries worldwide, disclosed to its stockholders that the Food and Drug Administration had assigned its New Drug Application (NDA) the status of Priority Review. And the regulator had also given the company a Prescription Drug User Fee Act date (PDUFA date) – also called Action date – of February 28, 2010. This is the day on which the Food and Drug Administration must finish complete its Priority Review of the new drug application and also send a response or feedback to Shire – specifically, telling the company whether it has approved its application or not.

Shire submitted the new drug application to get the regulator’s approval to market velaglucerase alfa – a drug that Shire has discovered and developed. The company claims that the drug can be used in the therapy of replacing enzymes – which, in turn, can develop a cure for Type 1 Gaucher Disease.

The company was very proud that the FDA has assigned its NDA a Priority Review. And the reason is clear. FDA assigns Priority Review designation only to those drugs that, it believes, would produce a major breakthrough in medicine. This is possible in only two ways – by providing a key development in treatment methods or by offering treatment for a medical condition which cannot be treated by any alternative method. The new drug application with Priority Review designations are reviewed with ten to six months from their dates of submission. This is a lot quicker than for those without Priority Review designations.

Even though velaglucerase alfa has not been approved by the Food and Drug Administration, Gaucher patients may be given the drug if the treatments are approved by the regulator. This phenomenon – known as “pre approval access program” – has happened in both US and in other countries. Shire is also planning to market the drug in Europe – where it will have to submit a Marketing Authorization Application to the European Union.