US regulators to speed up drug review

US drug regulators have agreed to speed up a review of Elan’s application to market a treatment for Multiple Sclerosis.

Elan and its development partner, Biogen Idec, submitted the Antegren product for review with the US Food and Drug Administration in May. The review process, which ensures that the drug is safe to go on the market, normally takes about 10 months. However, the FDA said it will decide in just six months. “The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need,” Elan said in a statement.

MS is a chronic disease of the central nervous system that affects approximately 400,000 people in the US and approximately one million people worldwide. It is a disease that affects more women than men, hitting most people between the ages of 20 and 40. Symptoms of MS include vision problems, loss of balance, numbness, difficulty walking and paralysis.

Elan, which has only recently returned to financial health, has high hopes for the success of Antegren. Some brokers believe the drug has the potential to be a blockbuster drug, capable of generating $1 billion in sales year.

The Irish firm has also looked at using Antegren for treatment of other illnesses, including Crohn’s disease, the bowel disorder. Last week Elan had some positive news on its Alzheimer’s treatment. It told a medical conference that the treatment - called AN1792, has shown signs of reducing plaques that form on patients’ brains.

A previous study had to halted when it emerged that the drug caused some patients’ immune systems to attack healthy brain tissue causing serious side effects.

Shares in Elan were down a touch on the Dublin market yesterday, but lost nearly 8% of their value in the US. The bulk of its shares are traded in New York.