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Old 12-16-2019, 03:47 PM
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Default FDA approves first generics of Gilenya

FDA approves first generics of Gilenya

For Immediate Release:
December 05, 2019

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines.”

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses or flare-ups, are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Gilenya is a widely used orally administered treatment option.

The most common side effects reported in the clinical trials for Gilenya include headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain and pain in the extremities.

Fingolimod must be dispensed with a Medication Guide that contains important information about its uses and risks. Serious risks include slowing of the heart rate, especially after the first dose. Fingolimod may increase the risk of serious infections. Patients should be monitored for infection during treatment and for two months after discontinuation of treatment. A rare brain infection that usually leads to death or severe disability, called progressive multifocal leukoencephalopathy (PML) has been reported in patients being treated with the drug. PML cases usually occur in patients with weakened immune systems. Fingolimod can cause vision problems. It may increase the risk for swelling and narrowing of the blood vessels in the brain (posterior reversible encephalopathy syndrome). Other serious risks include respiratory problems, liver injury, increased blood pressure and skin cancer. Fingolimod may cause harm to a developing fetus; health care professionals should advise women of child-bearing age of the potential risk to the fetus and to use effective contraception.

The FDA granted approvals of generic fingolimod applications to HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.

Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to more affordable medicines.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Old 02-12-2020, 11:09 PM
ThailandVal ThailandVal is offline
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I've been on Gilenya for about a year now and it's working really well for me but it does cost a fortune. I am a US citizen but I live in Thailand and the generic versions are not available here. I am thinking of going to the US to get a subscription for generic fingolimod. Does anyone here have any direct experience, such as how much less expensive is the generic really? And how many months worth of the medication do neurologists in the US usually prescribe? If I had to go back every few months to get it the plane fair would add up.
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