FDA Approves Novartis Gilenya Oral Pill for Multiple Sclerosis
Like diabetic patients not so long ago, people who suffer from multiple sclerosis have only injectable medication options to treat their symptoms. But that is about to change. The US Food and Drug Administration has approved an oral medication called Gilenya™ (generic fingolimod) which has been shown in clinical trials to significantly reduce relapses and delay the progression of disability.
Gilenya Reduces MS Relapses by 52%
Multiple Sclerosis (MS) is an autoimmune disease that affects the central nervous system. There is no cure, and symptoms commonly relapse (return after a period of remission). The goal of treatment is to control symptoms and help maintain a normal quality of life. About 400,000 Americans have MS.
“Today is a significant and encouraging day for people with relapsing forms of MS in the US,” said Nicholas LaRocca, Vice President of Healthcare Delivery and Policy Research at the National Multiple Sclerosis Society. “A new treatment option that offers significant efficacy in the convenience of a capsule is a welcome alternative to frequent injections for individuals living with this chronic disease.”
Gilenya belongs to a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. The medication is thought to work by reducing the immune system’s attack on the central nervous system by retaining certain white blood cells (lymphocytes) in the lymph nodes, preventing them from reaching the CNS. This results in less inflammatory damage to the nerve cells.
In clinical trials involving about 2,600 patients, Gilenya reduced the frequency of MS relapses by 52% at one year compared to the next most commonly prescribed treatment – interferon beta 1a IM. The risk of progressing into disability was significantly reduced in a two-year, placebo controlled study.
The drug also appeared to reduce the number of brain lesions detected by magnetic resonance imaging (MRI) – a measure of disease activity in people with relapsing forms of MS.
Gilenya overall appears to be safe, but the drug may cause some serious side effects, according to the drug’s prescribing information, which include slow heart rate (bradycardia or bradyarrhythmia), particularly after the first dose. This may cause patients to feel dizzy or tired. Doctors are asked to closely monitor a patient for six hours after the first dose is taken. The slow heart rate will usually return to normal within about one month.
Other potentially serious side effects include infection, macular edema, shortness of breath, and liver problems. Women who are pregnant should not take Gilenya, as it can harm the fetus. It is not known if Gilenya is passed through breastmilk, so nursing mothers are also warned not to take the drug.
For full prescribing information and the medication guide go to www.pharma.us.novartis.com.