For treating multiple sclerosis in the adult patients FDA has now approved three applications for the first generics of Gilenya (fingolimod) capsules in the USA. Food and Drug Administration (FDA) is an agency in the U.S. Department of health and human services. The goal of this agency is to protect the public health. This would be done by ensuring the effectiveness, safety, and security of veterinary and human medicine and also medical equipment, vaccines, and other biological products related to healthcare. The security of national food, dietary supplements, cosmetics, electronic radiation products, and tobacco products is also regulated by the FDA.
According to Janet Woodcock who is the director of FDA’s Center for Drug Evaluation and Research that it is a priority of the FDA to approve safe and effective generics drugs for the patients so that they may have more options for treatment. It is important to give access to the patients for affordable treatments with the conditions that provide ongoing care. FDA approved a longstanding commitment to enhancing access to the patients for low cost, and high-quality generic medicines.
Multiple sclerosis is an inflammatory, autoimmune and chronic disease of the central nervous system that disturbs the communication between the brain and the parts of the body. this the most common cause of the neurological disability among adults and women are more prone to this.
People having multiple sclerosis typically suffer from episodes of worsening functions and symptoms such as relapses or flare-ups. These relapses are initially followed by remissions. Increased disability and decline in function results if the recovery is not done properly. this leads to the progression of the disease with severe complications. Gilenya is the drug used for the treatment that can be administrated orally.
The clinical trials showed the common side effect due to the Gilenya includes elevation of liver enzymes, cough, influenza, headache, diarrhea, sinusitis, abdominal pain, back pain, and extremities pain.
Fingolimod must be prescribed according to medical guidance. It shows the vital information about the risks and its uses. After taking the first dose the heart rate becomes slowdown that is the serious risk factor. It also increases the chance of serious infections. After the treatment, monitoring of the patients must be done for the infections.
When patients treated with this drug progressive multifocal leukoencephalopathy (PML) is a report in many cases. It is an infection of a rare brain that is usually severe and fetal. Immune compromised patients are more susceptible to PML.
The drug can cause problems in the vision and increases the swelling and narrowing of blood vessels in the brain. This condition is called posterior reversible encephalopathy syndrome. The developing fetus is also affected by using Fingolimod. Many health care providers prescribed contraceptives medicine to women of childbearing age to reduce the risk to the fetus. Many serious risks include liver injury, increase blood pressure, respiratory problems and skin cancer.
For generic fingolimod applications, the approvals granted by FDA to HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited. FDA ‘s Drug Competition Action Plan includes the challenges to develop generics and to promote more generic competition. The agency is also putting substantial efforts to help the patients for getting affordable medications.