Iran Mass Producing Fingolimod MS Drug
TEHRAN (Tasnim) – Iran has launched the production line for fingolimod medicine (rINN, trade name Gilenya, Novartis), which is used for treating multiple sclerosis (MS) patients, the second country to do so after the US.
“Decoding the formula of filglomid medicine, which is used for treating and controlling the process of MS disease, took place a few months ago by our country’s pharmacologists and the Iranian version of the drug has been tested on 309 MS patients in various cities, with fine feedback,” Osweh Drug Company’s pharmacologist expert Dr. Babak Yazdani told Tasnim News Agency on Tuesday.
He said that the tests on MS patients had been conducted in full collaboration with the Health Ministry and the MS Patients Association, adding, the license for mass production of finglomid medicine has been obtained from the Iranian Food and Drug Administration and a number of doctors have been offered training courses.
Fingolimod would be of use to some but not all sufferers and would offer an alternative to the current treatments of injections and hospital infusions.
MS is the most common disabling neurological condition affecting young adults, which is the result of damage to myelin - the protective sheath surrounding nerve fibres of the central nervous system - which interferes with messages between the brain and the body.
For some people, MS is characterised by periods of relapse and remission while for others it has a progressive pattern. Symptoms range from loss of sight and mobility, fatigue, depression and cognitive problems. There is no cure and few effective treatments.
Symptoms include mobility problems, lack of bladder and bowel control and and blurred vision.
Fingolimod (rINN, trade name Gilenya, Novartis) is an immunomodulating drug, approved for treating multiple sclerosis. It has reduced the rate of relapses in relapsing-remitting multiple sclerosis by over a half. Fingolimod is a sphingosine 1-phosphate receptor modulator, which sequesters lymphocytes in lymph nodes, preventing them from contributing to an autoimmune reaction.
On September 22, 2010, fingolimod became the first oral disease-modifying drug approved by the US Food and Drug Administration to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis. Novartis announced on March 10, 2011 that it had received a notice of compliance from Health Canada and that the drug would be available April 1, 2011 at pharmacies.
On March 17, 2011, the European Medicines Agency approved the drug for use in the European Union.