FDA Delays Decision on Multiple Sclerosis Drug
According to Reuters, the U.S. Food and Drug Administration (FDA) has extended the review process for the multiple sclerosis drug Plegridy by three months as they evaluate an application for the drug’s approval.
About the Plegridy
Initially scheduled for launch in mid-2014, Plegridy is an injectable multiple sclerosis drug developed by Biogen to reduce the dosing schedule of standard interferon drugs like Avonex.
Typically, interferon drugs are dosed at least once a week. Unfortunately, the drugs can be hard to tolerate and carry flu-like symptoms, often leading to patient delaying or discontinuing treatment.
Biogen aims to increase treatment completion by limiting the number of necessary interferon injections, making the symptoms less of an occurrence.
Clinical trials for Plegridy have shown the drug to be well tolerated, meaning the drug could replace market leaders like Tysabri which has been linked to serious side effects including hypertension, hypersensitivity and death.
About Multiple Sclerosis
- Multiple sclerosis is a chronic condition that occurs when the body’s immune system mistakenly attacks and destroys the protective sheath surrounding the nerve cells in the brain, optic nerve or spinal cord.
- Over time, the damage can hinder communication between the brain, spinal cord and other areas of the body. The damage is not reversible.
- Symptoms include a loss of balance, difficulty moving arms and legs, weakness, numbness and blindness.
- While there is no cure for MS, treatment can reduce symptoms and reduce progression of the disease.